tag:blogger.com,1999:blog-4594923951980004712024-03-14T02:36:15.609-07:00Life Science Items of InterestSocial media enthusiast at the intersection of IT and Health care. Employee of The Drug Information Association: The Global Forum for Therapeutic Innovation & Regulatory Science - A Neutral, Nonprofit AssociationAnonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.comBlogger557125tag:blogger.com,1999:blog-459492395198000471.post-71883374133701852222013-10-16T10:53:00.000-07:002013-10-16T11:01:08.417-07:00DIA EuroMeeting 2014 Advance Programme now available ~ March 2014 in Vienna<table align="center" border="0" cellpadding="0" cellspacing="0" style="width: 600px;"><tbody>
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<tr><td rowspan="3" valign="top" width="322"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;">D</span></span></span><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;">IA and the EuroMeeting 2014 Programme Committee have worked hard over the past month to present you with an outstanding conference programme. We invite you to view the Advance Programme today, and to begin planning your attendance in March.</span></span></span><br />
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<a href="http://echo4.bluehornet.com/ct/25649064:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><img align="" alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/button_small_viewprogramme.gif" style="margin: 0px;" /></a></div>
<span style="color: #6b1f7c;"><span style="font-size: 14px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;">Let the Co-chairs tell you what will be special about this EuroMeeting and why you should come to Vienna in March</span></span></span></span></span></span><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><br /></span></span></span><br />
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<span style="color: #6b1f7c;"><span style="font-size: 14px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><a href="http://echo4.bluehornet.com/ct/25649065:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><img align="" alt="Watch the Co-chairs on YouTube" border="0" height="191" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/14101_chairs.gif" style="margin: 0px;" width="310" /></a></span></span></span></span></span></span></div>
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</td><td bgcolor="#cccccc" style="text-align: center;" width="222"><strong><span style="font-family: Arial;"><span style="color: #660066;">Advance Programme</span></span></strong></td></tr>
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<span style="font-size: 12px;"><span style="font-family: Arial;"><a href="http://echo4.bluehornet.com/ct/25649064:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #6b1f7c;"><strong>Download</strong></span></a><span style="color: #5e6167;"> the Advance Programme to find out more about themes, Theme Leaders, exhibition, hotels and travel.</span></span></span></div>
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<span style="color: #660066;"><strong><span style="font-size: 16px;"><span style="font-family: Arial;">Programme Co-chairs</span></span></strong></span></div>
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<tr><td valign="middle" width="86"><img align="" alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/Joos-Angelika_80x110.gif" style="margin: 0px;" /></td><td width="172"><span style="color: #5e6167;"><strong><span style="font-size: 12px;"><span style="font-family: Arial;">Angelika Joos</span></span></strong><span style="font-size: 12px;"><span style="font-family: Arial;"><br /> Head Regulatory Policy EU and Most of World, Merck Sharp and Dohme, Belgium</span></span></span></td><td valign="middle" width="86"><img align="" alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/Muellner-Markus_80x110.gif" style="margin: 0px;" /></td><td valign="middle" width="149"><span style="color: #5e6167;"><strong><span style="font-size: 12px;"><span style="font-family: Arial;">Marcus Müllner</span></span></strong><span style="font-size: 12px;"><span style="font-family: Arial;"><br /> Head, Austrian Medicines and Medical Devices Agency (AGES)</span></span></span></td></tr>
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EuroMeeting 2014 Topics of Global Relevance</span></span></span></strong></span></span></span></td></tr>
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<strong><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;">The links will take you directly to the right page of the programme</span></span></span></span></span></span></span></span></strong></div>
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<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649068:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Tutorial 9:</strong> Early Access Schemes: Considerations for developing regulatory strategies</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><br />
<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649069:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Tutorial 13:</strong> Clinical Trials in Emerging Markets: Fostering strategic relationships, building capacity and enhancing capability</span></a></span></span></span></span></span></span></span></span></span></span></span></div>
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<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649070:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 0105:</strong> Biosimilars – Building on European foundations to achieve global harmonisation</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><br />
<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649071:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 0107:</strong> Optimising Regulatory Operations Through Use of Information Technology</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></div>
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<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649072:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 1002:</strong> Surviving Safety and Quality Inspections in the Era of Globalisation: Harmonising systems and processes across company units</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><br />
<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649073:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 1005:</strong> Global Submission and Review Strategy – How rapidly Innovation can reach global markets</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span><br />
<span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649073:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 1007:</strong> Current Status and Future Challenges of Asian Regulatory Environment</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></div>
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<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649074:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 1205:</strong> Quality by Design (QbD) and Innovation in Development and Manufacturing</span></a></span></span></span></span></span></span></span></span></span></span></span></div>
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<span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649075:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 1402:</strong> Innovation Through Public-Private Partnership Collaborations</span></a></span></span></span></span></span></span></span></span></span></span></span><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><br /></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></div>
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<span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="color: #6b1f7c;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649076:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Session 1604:</strong> Regulatory Intelligence in Practice – How regulatory authorities inform about decision making</span></a></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></span></div>
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<span style="color: #5e6167;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><span style="font-family: Arial;"><span style="font-size: 12px;"><a href="http://echo4.bluehornet.com/ct/25649077:24164223670:m:N:1378935879:F6575CBA76E7F539D772BA089DD9B7BE"><span style="color: #003591;"><strong>Stand-Alone Session:</strong> Japanese Regulatory Session/PMDA Update</span></a></span></span></span></span></span></span></span></span></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-66734158932440459922013-10-16T07:27:00.000-07:002013-10-16T07:27:59.273-07:00第六届DIA中国年会 ~ 展览、会议支持及广告的绝佳机会!<div style="text-align: left;">
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第六届DIA中国年会</h1>
<div class="p2" style="color: #6c2d60; font-family: Arial, Helvetica, 黑体, sans-serif; font-size: 13px; line-height: 1.5em; margin-top: 10px;">
2014年5月11日:会前研讨班<br />
2014年5月12-14日:会议、展览及壁报<br />
<strong>地点:上海国际会议中心</strong></div>
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特级支持方</h4>
<img align="" alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/14975_Q_hor_pos_full_rgb_redqblacktext.gif" style="margin: 0px;" /><br />
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展商列表</h4>
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<li>Bestudy</li>
<li>BioClinica</li>
<li>Fountain Medical Development</li>
<li>ICON</li>
<li>Integrated</li>
<li>Medidata</li>
<li>NNIT</li>
<li>PAREXEL</li>
<li>Quintiles</li>
<li>Theorem Clinical Research</li>
<li>Tigermed</li>
<li>World Courier</li>
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相关链接</h4>
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<li>展位合同及申请表<br />(<a href="http://echo4.bluehornet.com/ct/25694024:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">英文</span></a> | <a href="http://echo4.bluehornet.com/ct/25694025:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">中文</span></a>)</li>
<li><a href="http://echo4.bluehornet.com/ct/25694026:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">展位图</span></a></li>
<li><a href="http://echo4.bluehornet.com/ct/25694027:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">会议支持机会</span></a></li>
<li>广告申请表<br />(<a href="http://echo4.bluehornet.com/ct/25694028:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">英文</span></a> | <a href="http://echo4.bluehornet.com/ct/25694029:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">中文</span></a>)</li>
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展览、会议支持及广告的绝佳机会!</h3>
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与来自国内外生物制药行业、合同服务机构、监管机构、药品生命周期管理、医疗器械及其它相关医疗产品行业的专业人士一起,就共同关心的话题展开深入的交流与探讨。</div>
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展览</h3>
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三种不同的3米X3米展位级别供您选择!现在就预定您的展位</div>
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<a href="http://echo4.bluehornet.com/ct/25694024:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">英文版展位合同及申请表</span></a> <br />
<a href="http://echo4.bluehornet.com/ct/25694025:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">中文版展位合同及申请表</span></a></div>
<h3 style="color: #6c2d60; font-family: Arial,Helvetica,黑体; font-size: 13px; font-weight: bold; margin-bottom: 6px; margin-top: 13px;">
广告</h3>
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终版会刊手册中为您提供了几种广告机会,包括封二、封三、内页单页全页广告、半页广告、通栏广告及标签页广告 (<a href="http://echo4.bluehornet.com/ct/25694028:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">英文版广告申请表 </span></a>| <a href="http://echo4.bluehornet.com/ct/25694029:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">中文版广告申请表</span></a> )。</div>
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会议支持</h3>
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DIA 还为您提供了不同类型的会议支持机会,如特级支持方<strong> [已售]</strong>, 一级支持方<strong> [已预定]</strong>, 二级支持方,展厅交流招待会,VIP招待会及茶歇等。</div>
<div style="color: #5f6168; font-family: Arial, Helvetica,黑体,sans-serif; font-size: 13px; font-weight: normal; line-height: 1.5em; margin-top: 2px;">
为满足您有更多产品/服务展示的需求,我们还为您提供了以下<strong>新的会议支持机会:</strong></div>
<ul style="color: #5f6168; font-family: Arial, Helvetica,黑体, sans-serif; font-size: 13px; font-weight: normal; line-height: 1.5em; margin-left: 15px; margin-top: 2px; padding-left: 15px;">
<li>创新展示区</li>
<li>会议中心大堂LED广告</li>
<li>展厅地毯贴</li>
<li>展商信息板公司宣传页定位展示</li>
<li>饮水机</li>
</ul>
<div style="color: #5f6168; font-family: Arial, Helvetica,黑体,sans-serif; font-size: 13px; font-weight: normal; line-height: 1.5em; margin-top: 2px;">
关于更多会议支持机会及预定,请参见<a href="http://echo4.bluehornet.com/ct/25694027:24164587400:m:N:1378935879:4F133A5547194C1EEC975AC7663839E4"><span style="color: #003591;">会议支持机会申请表 </span></a></div>
<h3 style="color: #6c2d60; font-family: Arial,Helvetica,黑体; font-size: 12px; font-weight: bold; margin-bottom: 6px; margin-top: 15px;">
展位、广告及会议支持更多信息,请联系徐迎宾(Jean Xu,<a href="mailto:jxu@kellencompany.com"><span style="color: #003591;">jxu@kellencompany.com</span></a>),Sofie Peeters (<a href="mailto:speeters@kellencompany.com"><span style="color: #003591;">speeters@kellencompany.com</span></a>)或拨打电话 +86 10 5923 1096</h3>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-76855330431468878532013-10-11T06:01:00.000-07:002013-10-11T06:01:06.965-07:00The founder of the European Medicines Agency (EMA), Fernand Sauer, will give the keynote speech at 10th Annual Meeting DIA Japan.<div style="text-align: left;">
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<td align="left" bgcolor="#b6b1a9" valign="middle"><a href="http://echo4.bluehornet.com/ct/25519490:24126586577:m:N:1378935879:E83421213EF3210BE3483AD977E1FDC3" meeting=""><img alt="10th Annual Meeting DIA Japan 2013" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/13303_EN_600x150.gif" style="margin: 0px;" /></a></td></tr>
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<td align="left" style="padding: 14px 14px 20px;" valign="top"><span style="font-family: Arial;"><span style="color: #003591;"><span style="font-size: 22px; line-height: 30px;"><strong>One Month Left to Book Your
Seat to Hear Fernand Sauer and Other Prominent
Speakers</strong></span></span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">The founder of the European Medicines
Agency (EMA), Fernand Sauer, will give the keynote speech at <a href="http://echo4.bluehornet.com/ct/25519491:24126586577:m:N:1378935879:E83421213EF3210BE3483AD977E1FDC3">10th
Annual Meeting DIA Japan</a>.</span></span><br />
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<td align="left" style="padding: 0px 15px 5px 0px;" valign="top"><img alt="Fernand Sauer" border="0" height="136" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/13303_fsauer_110x150.gif" style="margin: 0px;" width="100" /></td></tr>
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<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">Mr. Sauer joined the European
Commission in Brussels in 1979 and was involved in European pharmaceutical
harmonization, playing a key role in launching the harmonisation of regulatory
requirements (ICH) with the US and Japan. In 1994 he created the EMA and became
its first Executive Director until 2000. He is currently a member of the French
Academy of Pharmacy and, as Honorary Director General of the European
Commission, he continues to advise European Institutions and EU agencies on
health and pharmaceutical issues. In 2006 Mr. Sauer received the DIA
Distinguished Career Award.</span></span><br />
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<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">The meeting, to be held from November
6-8, will bring together academia, regulatory agencies, industry, and patients
to discuss how to move ahead with the discovery and fostering of innovative
drugs. </span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">The wide variety of sessions across
six tracks will cover topics such as the role of academic research
organizations, regenerative medicine, companion diagnostics, and discussion of
the current issues in ICH featuring representatives from global regulators.
Attendees will also enjoy high profile networking
opportunities.</span></span><br />
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<li><span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">Drug Development Through
Collaboration with ARO and Future </span></span>
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Development</span></span>
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<li><span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">Effective Consultation Strategy in
Global Development based on Consultation Examples from Japan and Other
Regions</span></span>
<li><span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">Globalization of ICH
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the Development of Companion Diagnostics and Personalized
Medicine</span></span>
<li><span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">The Regulation, Development, and
Future of Biosimilars</span></span> </li>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-84141381512132173972013-10-10T07:06:00.000-07:002013-10-10T07:07:14.347-07:00Insights From Canada’s Thought Leaders on Patient’s Voice, Plain Language Labeling Project, Pharmacovigilance<div style="text-align: left;">
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<strong><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 15pt;">Exclusive Scoop from
Canada's Key Thought Leaders</span></strong><span style="color: #003591; font-family: "Arial","sans-serif"; font-size: 21pt;"><o:p></o:p></span></div>
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<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">In this edition of the <a href="http://echo4.bluehornet.com/ct/25372972:24121153275:m:1:1378935879:8952284D7F5DCB115E8969D4E1BF2C8D:r"><em><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">Insider Update</span></span></em></a>
you’ll hear insights from Canada’s key industry thought leaders regarding
the impact of patient’s voice in the ever changing regulatory
environment, the emerging areas of change in Pharmacovigilance in Canada,
and what international regulatory cooperation means to key stakeholders
in the development and regulation of health products. In addition, we
will address the need to provide the patient and the health care
professional with increased accessibility to drug information and
comprehension of drug labels, plus more.</span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span> </div>
<div align="center" style="line-height: 13.5pt; text-align: center;">
<em><b><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;">“Those
who are in the pharmaceutical industry and those in the regulatory realm </span></b></em><b><i><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
<em><span style="font-family: "Arial","sans-serif";">need to acknowledge
the patients’ voice and perspective."</span></em><br />
<br />
<em><span style="font-family: "Arial","sans-serif";">"New approaches
and collaborations are required to keep up with the </span></em><br />
<em><span style="font-family: "Arial","sans-serif";">realities of the
pharmaceutical industry today..."</span></em></span></i></b><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
<div align="center" style="line-height: 13.5pt; text-align: center;">
<strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">Get
the Insider Scoop NOW!</span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">
</span></strong><b><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><img align="" border="0" id="_x0000_i1029" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" /><strong><span style="font-family: "Arial","sans-serif";"> <a href="http://echo4.bluehornet.com/ct/25372972:24121153275:m:1:1378935879:8952284D7F5DCB115E8969D4E1BF2C8D:r"><span style="color: #003591;">Read
More</span></a> </span></strong></span></b><em><b><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;">Insider Update </span></b></em><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-53104078832513423102013-10-09T06:11:00.000-07:002013-10-09T06:11:30.301-07:00第10回DIA日本年会 ~ 早期割引は10/16まで。この機会をお見逃しなく!<div style="text-align: left;">
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<td align="left" style="padding: 14px 14px 20px;" valign="top"><span style="color: #003591;"><span style="font-size: 22px; line-height: 30px;"><strong><a href="http://echo4.bluehornet.com/ct/25398456:24102529797:m:N:1378935879:7CA4BEEA5D734226E608B9B9AD95D2AA">第10回DIA日本年会</a> </strong></span></span><br />
<span style="color: #003591;"><span style="font-size: 22px; line-height: 30px;"><strong>(早期割引は10/16まで。この機会をお見逃しなく!</strong></span></span><span style="color: #003591;"><span style="font-size: 22px; line-height: 30px;"><strong>)</strong></span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">今年の日本年会は、委員長に千葉大学学長 齋藤
康先生をお迎えし、「日本発の創薬革命 ~ 革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割 ~」をテーマに、3日間6トラックのプログラム構成で臨床
/ 薬事 / 統計 / 安全性 / プロジェクトマネジメント / データマネジメント / CMC / メディカルライティング / シックスシグマ / HTA
/ 患者会等の各領域に関連した数多くセッションが企画されています。</span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">年会のオープニングに先立つ初日の午前中には、チュートリアルセッションとスチューデント
セッションが設けられ、基調講演では、European Medicines Agency (EMA) およびICHの創立者であるFernand
Sauer氏、並びに、Duke Clinical Research Institute (DCRI) 設立者のRobert M.
Califf氏をお迎えしてご講演いただきます。なお、3日目のDIA日本年会第10回記念ラウンドテーブルの前には、医薬品医療機器総合機構
近藤理事長の特別講演も予定されています。また、初日夜の情報交換会に加え、2日目夜にも産官学の若手中心の意見交換会も開催され、貴重なネットワーキングの機会になるものと考えております。</span></span><span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;"><br /></span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">更に、今年の大きな特色の一つとして、ICH大阪会議の直前に開催されることから、海外規制当局の方々を初めとする多くのICH関係者が、演者もしくはパネリストとしてご参加される予定です。</span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">ぜひ<a href="http://echo4.bluehornet.com/ct/25398457:24102529797:m:N:1378935879:7CA4BEEA5D734226E608B9B9AD95D2AA">こちら</a>よりご登録の上、ご参加いただきますよう、よろしくお願い申し上げます。</span></span><br />
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<a href="http://echo4.bluehornet.com/ct/25398456:24102529797:m:N:1378935879:7CA4BEEA5D734226E608B9B9AD95D2AA">第10回DIA日本年会サイトはこちら</a>
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<a href="http://echo4.bluehornet.com/ct/25398459:24102529797:m:N:1378935879:7CA4BEEA5D734226E608B9B9AD95D2AA" meeting="">申込はこちら</a></div>
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<span style="font-size: 16px;"><strong><span style="color: #003591;">出展及び特別協賛のご案内</span></strong></span></div>
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">本年会では、展示に於きましても新しい企画を試みており、約900平米という大きな展示スペースを活かし、ランチタイムやコーヒーブレイクタイムでの企業によるプレゼンテーションなど、これまでとは違った本格的展示企画をご用意しております。</span></span><br />
<div style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 18px;">
このチャンスにぜひご出展いただき、貴社、貴団体の更なるご発展の機会にしていただければ幸いです。</div>
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詳細は<a href="mailto:DIAJapan@diajapan.org?subject=Exhibiting%20Opportunities">DIA
Japan</a>までお問い合わせください。 <br />
Tel: +81-3-5575-2130<br />
Fax:
+81-3-3583-1200<br />
Email: <a href="mailto:DIAJapan@diajapan.org?subject=Exhibiting%20Opportunities">DIAJapan@diajapan.org</a></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-73571716426693449232013-10-08T05:50:00.000-07:002013-10-08T05:51:42.529-07:00Move Toward Better Communication and Collaboration Among Patients, Payers, and Product Developers<div style="text-align: left;">
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<span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 16.5pt;">Move
Toward Better Communication and Collaboration Among Patients, Payers, and
Product Developers </span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"> <o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">DIA and the Brookings Institution are
collaborating to strengthen communication between health care stakeholder
communities. <a href="http://echo4.bluehornet.com/ct/24955949:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><strong><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">A Model of Patient, Payer, and
Product Developer Collaboration to Support Innovating for Value</span></span></strong></a>
will focus on highlighting the perspectives and outcomes most relevant to
patient communities, reimbursement requirements and innovative payment
models of most interest for payer groups, and how both can help inform
product developers as they drive toward novel value-based innovation.<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">By exploring these issues and setting
an actionable agenda for improving communication moving forward, this
conference will be an important step toward ensuring that patients,
payers, and product developers are each contributing to the creation of
cost-effective, quality-producing therapies.<o:p></o:p></span></div>
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October 9!</span> </span></em><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24955951:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><span style="color: #003591;"> <img align="" border="0" id="_x0000_i1032" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" /></span></a> <a href="http://echo4.bluehornet.com/ct/24955949:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><span style="color: #003591;">Overview</span></a>
| <a href="http://echo4.bluehornet.com/ct/24955951:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><span style="color: #003591;">Register
Today</span></a><a href="http://echo4.bluehornet.com/ct/24955951:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><br /><span style="color: #003591;">
</span></a><o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">Session Topics:</span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
• Aligning Perspectives on Value and Outcomes<br />
• Identifying Stakeholder Needs and Challenges
to Strategic Communication<br />
• Exploring Opportunities for Efficient
Engagement Throughout Discovery, <br />
Clinical Development, Regulatory
Review, and Product Use<br />
• Case Studies and Current Initiatives<br />
• Next Steps: Charting a Course Forward<br />
• And More<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">Keynote Speaker: </span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
• <strong><span style="font-family: "Arial","sans-serif";">James
Heywood,</span></strong> Co-Founder, Chairman, PatientsLikeMe<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">Confirmed Speakers:</span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
• <strong><span style="font-family: "Arial","sans-serif";">Anne
C. Beal, MD, MPH,</span></strong> Chief Operating Officer,
Patient-Centered Outcomes Research Institute<br />
• <strong><span style="font-family: "Arial","sans-serif";">Marc
M. Boutin, JD,</span></strong> Executive Vice President and Chief
Operating Officer, National Health Council<br />
• <strong><span style="font-family: "Arial","sans-serif";">Shari
M. Ling, MD,</span></strong> Deputy Chief Medical Officer, Centers for
Medicare & Medicaid Services<br />
Center for Clinical Standards &
Quality<br />
• <strong><span style="font-family: "Arial","sans-serif";">Sean
R. Tunis, MD, MSc,</span></strong> President and CEO, Center for Medical
Technology Policy<br />
• <strong><span style="font-family: "Arial","sans-serif";">Rhonda
M. Medows, MD, FAAFP,</span></strong> Executive Vice President &
Chief Medical Officer<br />
UnitedHealthcare<br />
• <strong><span style="font-family: "Arial","sans-serif";">Tehseen
Salimi, MD,</span></strong> Vice President of Global Evidence and Value
Development, Sanofi Aventis<br />
• <strong><span style="font-family: "Arial","sans-serif";">Frances
M. Visco,</span></strong> President, National Breast Cancer Coalition<br />
• <strong><span style="font-family: "Arial","sans-serif";">Reed
V. Tuckson, MD, FACP,</span></strong> Managing Director, Tuckson Health
Connections, LLC<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">Who Should Attend? </span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
• Patient groups interested in strengthening
patient involvement in medical product development<br />
• Payer groups involved in reimbursement for
innovative new products<br />
• Product developers considering the role of
external stakeholders in the creation of cost-effective, <br />
quality producing medical products<br />
• Regulators, providers, and academic
researchers pursuing cross-sector collaboration to <br />
improve health care stakeholder
communication<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">Co-sponsored by:
</span></strong><b><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;"><img align="" border="0" height="38" id="_x0000_i1033" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/DIA_50th_Logo_gray_138x55.jpg" width="95" /><strong><span style="font-family: "Arial","sans-serif";">
</span></strong><img align="" border="0" id="_x0000_i1034" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/Logo_Engelberg_Brookings_150x35.gif" /></span></b><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<strong><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">More Exciting Offerings:</span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24955952:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><strong><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">US Conference on Rare Diseases
& Orphan Products: The New Era in Health Care</span></span></strong></a><br />
October 7-9 | North Bethesda, MD<br />
<strong><span style="font-family: "Arial","sans-serif";">Co-sponsored with
National Organization for Rare Disorders</span></strong><o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">The annual conference where all
stakeholders in the rare disease/orphan product community convene to
focus on rare diseases and orphan product research, development, and
access. <a href="http://echo4.bluehornet.com/ct/24955953:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><strong><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">Search the Online Program.</span></span></strong></a><o:p></o:p></span></div>
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<span style="mso-fareast-font-family: "Times New Roman";"><img align="" border="0" id="_x0000_i1037" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_13022_40x40.jpg" /><o:p></o:p></span></div>
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<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24955954:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><strong><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">Beginning with the End in Mind –
Study Endpoints: Targeting Patient-Centered Outcomes</span></span></strong></a><br />
October 21-23 | North Bethesda, MD | </span><em><span style="color: #cc6600; font-family: "Arial","sans-serif"; font-size: 9pt;">Register by
September 30 and Save up to $200!</span></em><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">Gain insight into the tradeoffs and
various stakeholder perspectives for developing a study endpoint
measurement strategy, including detailed and practical tips for ensuring
that measurement tools are adequate to support the targeted objectives
with a focus on establishing instrument content validity for the
specified clinical trial context of use.<o:p></o:p></span></div>
<table align="left" border="0" cellpadding="0" cellspacing="0" class="MsoNormalTable" style="height: 61px; mso-cellspacing: 0in; mso-padding-alt: 0in 0in 0in 0in; mso-table-anchor-horizontal: column; mso-table-anchor-vertical: paragraph; mso-table-left: left; mso-table-lspace: 2.25pt; mso-table-rspace: 2.25pt; mso-yfti-tbllook: 1184; width: 55px;">
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<td style="background-color: transparent; border: rgb(0, 0, 0); height: 45pt; padding: 0in;" valign="top"><div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="mso-fareast-font-family: "Times New Roman";"><img align="" border="0" id="_x0000_i1038" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_14013_40x40.jpg" /><o:p></o:p></span></div>
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<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24955955:24036609744:m:1:1378935879:DA7653E58DC3B055627C9A372C9BE1DF:r"><strong><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">Benefit-Risk Assessment from
Inception to Maturation: </span></span></strong><b><br /><span style="color: #003591;">
<strong><span style="font-family: "Arial","sans-serif";">Aligning
Regulatory and Industry Goals </span></strong></span></b></a><br />
February 10-14 | Bethesda, MD<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">Join FDA, EMA, Health Canada, and
other regulatory agencies, patient, industry and academic representatives
to discuss the progress and application of Benefit-risk assessment
throughout the development and post-approval life cycle.<o:p></o:p></span></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-5672539926819019472013-10-08T05:18:00.000-07:002013-10-08T05:18:54.739-07:00Exclusive Offer to DIA Members: Register for Two Webinars and Save $250.<div style="text-align: left;">
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<span style="color: #cc6600;"><span style="font-size: 16px;"><span style="line-height: 24px;">Check Out These Hot Topics:</span></span></span><span style="color: #003591;"><span style="font-size: 22px; line-height: 24px;"><br /></span></span><br />
<a href="http://echo4.bluehornet.com/ct/25374052:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>The
Current State of Quality Oversight in the Pharmaceutical
Industry</strong></a><br />October 9 | 11:00AM-12:30PM ET<br />
With definitions remaining unclear as to what, exactly, quality oversight
(QO) should entail and how optimal quality oversight programs can be effected.
This webinar will provide a definition of QO and delve deeper into the state of
QO today.<br />
<a href="http://echo4.bluehornet.com/ct/25374053:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>Connecting
the Right Sites to Promising Trials: The Role of Web-based Feasibility
Assessment</strong></a><br />October 23 | 11:00AM-12:30PM ET<br />
This webinar will address common weaknesses in the established process of
feasibility assessments and site selection, from the point of view of both trial
planners and research centers. The speakers will review relevant key performance
indicators (KPIs) and how to address them, global country selection strategies,
and better management of site feasibility assessment.<br />
<a href="http://echo4.bluehornet.com/ct/25374054:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>FDASIA
Year in Review</strong></a><br />October 24 | 11:00AM-12:30PM ET<br />
Hear what FDASIA has given us this past year – and what we might expect in
the coming year. This webinar will focus on the progress of the PDUFA V and
initiatives to promote innovation and speed to patient access covering: user fee
levels, perspective on the new molecular entity review process, status update on
Benefit-risk assessment activities, and FDA’s interpretation of the fast track,
breakthrough therapy, accelerated approval, and priority review programs.<br />
<a href="http://echo4.bluehornet.com/ct/25374055:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>CDER
Town Meeting: Safety Hot Topics</strong></a><br />October 30 | 2:30-4:00PM ET<br />
In this interactive webinar, participants will submit questions regarding
safety to senior leadership from the US FDA Center for Drug Evaluation and
Research through an anonymous, computerized Q&A function.<br />
<a href="http://echo4.bluehornet.com/ct/25374056:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>CardioVascular
Safety: The New Paradigm - Proarrhythmic Assessment <br />of New Drugs Without the
Thorough QT Study</strong></a><br />October 31 | 11:00AM-12:30PM ET<br />
Explore the current approach to assessing the possible proarrhyrhmic
potential of drugs and its strengths and weaknesses, a new paradigm that relies
more fully on preclinical testing and its advantages and challenges, and key
regulatory issues surrounding implementing a new paradigm.<br />
<a href="http://echo4.bluehornet.com/ct/25374057:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>CardioVascular
Safety – What are the Key Issues Regarding Blood Pressure <br />Assessment During
Clinical Development</strong></a><br />November 7 | 11:00AM-12:30PM ET<br />
Explore the current approach to assessing the possible proarrhyrhmic
potential of drugs and its strengths and weaknesses, a new paradigm that relies
more fully on preclinical testing and its advantages and challenges, and key
regulatory issues surrounding implementing a new paradigm.<br />
<a href="http://echo4.bluehornet.com/ct/25374058:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>Aligning
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11:00AM-12:30PM ET<br />
Several legislations have been introduced calling for regulatory reform in
the health care process. FDA is under pressure from industry to enable a
regulatory framework for translational medicine but at the same time preserve
the public health. This 90-minute webinar will show how important it is for the
patient voice to be included when these legislations are drafted.<br />
<span style="color: #cc6600;"><span style="font-size: 16px;">More Upcoming
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<a href="http://echo4.bluehornet.com/ct/25374059:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>Practical
Aspects and Examples of Using Large Datasets for Identifying and
<br />Investigating Product Safety and Effectiveness in the US and
EU</strong></a><br />November 18 | 11:00AM-12:30PM ET<br />
<a href="http://echo4.bluehornet.com/ct/25374060:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>The
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<a href="http://echo4.bluehornet.com/ct/25374063:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>Combination
Products and Convergence: An Overview of Clinical Benefits, <br />Regulatory
Issues & Manufacturing Challenges</strong></a><br />December 5 |
11:00AM-12:30PM ET<br />
<a href="http://echo4.bluehornet.com/ct/25374064:24091523471:m:N:1378935879:C18E48A5771117685339DEDD433DCFCA"><strong>Global
Overview - Economic Power in Asian Countries</strong></a><br />December 11 |
11:00AM-12:30PM ET<br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-66279731002246371092013-10-03T07:32:00.001-07:002013-10-03T07:32:01.574-07:00<div style="text-align: left;">
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<strong><span style="color: #d52b1e; font-family: "Arial","sans-serif"; font-size: 16.5pt;">Receive a Year’s Free DIA
Membership when You Attend DIA India’s 8th Annual Conference </span></strong><span style="color: #003591; font-family: "Arial","sans-serif"; font-size: 21pt;"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">DIA is offering you the chance to
receive a year’s complimentary DIA membership when you attend DIA India’s
<a href="http://echo4.bluehornet.com/ct/25139695:24052953307:m:1:1378935879:60B8DCD1A488363438E21A8455143F57:r"><span style="color: #003591;">8th
Annual Conference</span></a>, coming to Bangalore in three weeks’ time.<o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">The event, to be held from October 24
to 26, will bring together academia, industry, regulators and researchers
to discuss the challenging new environment for health care product
development.<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">More than 90 renowned experts will
speak on key issues, including keynote presenters Prof. Ranjit
Roychaudhuory, Chairman of the Task Force for Research at Appollo
Hospitals Group, and Mukhtar Ahmed, Oracle HSGBU’s Vice President of
Product Strategy.<o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">The conference will also feature 12
tracks with 48 sessions on the key themes of clinical research, IT, life
sciences, medical writing, and biostatistics.<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">All conference attendees will each
receive a year’s free DIA membership. So don’t miss out – <a href="http://echo4.bluehornet.com/ct/25139696:24052953307:m:1:1378935879:60B8DCD1A488363438E21A8455143F57:r"><span style="color: #003591;">book
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TO OUR MEDIA<br />
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<span style="color: #d52b1e; font-family: "Arial","sans-serif"; font-size: 13.5pt;">Session highlights:</span><span style="color: #003591; font-family: "Arial","sans-serif"; font-size: 13.5pt;"><o:p></o:p></span></div>
<ul type="disc">
<li class="MsoNormal" style="color: #5f6168; line-height: 13.5pt; margin: 0in 0in 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">The New Clinical Research
Environment<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #5f6168; line-height: 13.5pt; margin: 0in 0in 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Vaccine Development – A
Challenge Like No Other<o:p></o:p></span></li>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-50705528191956219872013-10-03T07:23:00.001-07:002013-10-03T07:26:26.898-07:00DIA's Annual Canadian Meeting: New Reality/New Frontiers<div style="text-align: left;">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24939047:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><img align="" border="0" id="_x0000_i1034" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_14002_120x240.gif" /></a><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24939041:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><strong><span style="font-family: "Arial","sans-serif";"><span style="color: #003591;">DIA's Annual Canadian Meeting:
New Reality/New Frontiers</span></span></strong></a><br />
</span><em><b><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;">DIA Members Save $150. Early-bird expires October 7.</span></b></em><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Collaborate with key stakeholders: boost awareness and
deliver value to today’s patient reality driving change in drug
development and regulations. At this Annual Meeting, stakeholders from
industry, regulatory agencies, academic researchers, patient and patient
advocacy groups will have the opportunity to work together to recognize
the challenges faced by the industry and regulators in drug development,
market access, and regulations in Canada. <o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;">Opening Remarks:</span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<div style="line-height: 13.5pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">Kathryn McDade <br />
Assistant Deputy Minister of the Health Products and Food Branch<br />
Health Canada<o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;">Plenary Sessions: </span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
• International Regulatory Cooperation<br />
- <a href="http://echo4.bluehornet.com/ct/24939048:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Trends
and Impacts</span></a><br />
- <a href="http://echo4.bluehornet.com/ct/24939049:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Stakeholder
Perspective</span></a><o:p></o:p></span></div>
<div style="line-height: 13.5pt;">
<strong><span style="color: #6b1f7c; font-family: "Arial","sans-serif"; font-size: 9pt;">Break Out Sessions: </span></strong><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><br />
• <a href="http://echo4.bluehornet.com/ct/24939050:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Harmonizing
in the Post-Approval Pharmacovigilance:</span></a> <br />
<a href="http://echo4.bluehornet.com/ct/24939050:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Challenges
and Opportunities </span></a><br />
• <a href="http://echo4.bluehornet.com/ct/24939051:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Social
Media</span></a><br />
• <a href="http://echo4.bluehornet.com/ct/24939052:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Update
on ICH: What You Need to Know</span></a><br />
• <a href="http://echo4.bluehornet.com/ct/24939053:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Research
Networks and Translational Medicine</span></a><br />
• <a href="http://echo4.bluehornet.com/ct/24939054:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Support
Programs: The Pursuit of Patient Advocacy</span></a><br />
• <a href="http://echo4.bluehornet.com/ct/24939055:24057149022:m:1:1378935879:DB67B38FB932DB107F1CAD9752FA22E8:r"><span style="color: #003591;">Update
on the Legislative and Regulatory Modernization Initiative</span></a><br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-22117690790155117812013-09-27T05:09:00.000-07:002013-09-27T05:09:35.910-07:00DIA Advanced Regulatory Affairs トレーニングコース開催のご案内(応募期間を10/3迄に延長しました。)<div style="text-align: left;">
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<span style="color: #d52b1e; font-family: "Arial","sans-serif"; font-size: 13.5pt;">DIA Advanced Regulatory Affairs </span><span style="color: #d52b1e; font-family: "MS Gothic"; font-size: 13.5pt; mso-bidi-font-family: "MS Gothic";">トレーニングコース開催のご案内(応募期間を</span><span style="color: #d52b1e; font-family: "Arial","sans-serif"; font-size: 13.5pt;">10/3</span><span style="color: #d52b1e; font-family: "MS Gothic"; font-size: 13.5pt; mso-bidi-font-family: "MS Gothic";">迄に延長しました。)</span><span style="color: #003591; font-family: "Arial","sans-serif"; font-size: 21pt;"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">この度、</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">11</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">月</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">6</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">日(水)に</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">DIA Advanced Regulatory Affairs </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">トレーニングコースを開催することとなりましたので、ご案内申し上げます。本トレーニングは、今までに</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">6</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">回開催致しました</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">DIA Regulatory Affairs </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">トレーニングコースの参加者の皆様よりいただきましたご意見を踏まえ、架空の薬剤をモデルとして、審査担当者の立場で、「承認」、「不承認」を決断していただくとともに、ファシリテーターの演じる様々なステイクホルダーへの説明責任について学んでいただく内容となっております。本コースが皆さんの視野をさらに広げるきっかけとなり、実際の業務でもお役に立つものと確信しております。他にはない趣向を凝らした内容ですので、ぜひご参加ください。</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"></span><span style="mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">場所:</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">
TFT</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">東京ファッションタウンビル</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">研修室</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"> 905</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">(東館</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">9</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">階)</span><span style="mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">参加対象</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">: </span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">企業において薬事を担当している方(薬事経験</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">5</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">年以上が望ましい)または</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">PMDA</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">において審査・調査を担当している方(審査・調査経験</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">3</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">年以上が望ましい)</span><span style="mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">* </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">コースの趣旨を理解され、相応の経験を有している方でしたら、薬事担当者でなくてもご受講が可能です。</span><span style="mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">募集人数 : </span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"> 32</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">名(</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">8</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">名</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">/</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">グループ</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">× 4</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">グループ)</span><span style="mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">応募期間 : </span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"> </span><u><span style="color: red; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">10</span></u><u><span style="color: red; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">月</span></u><u><span style="color: red; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">3</span></u><u><span style="color: red; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">日(木)まで</span></u><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">*</span><span style="color: red; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">お席に僅かな余裕がございますので、応募期間を延長致しました。定員となり次第、申込を締め切ります。お早めにお申込ください。</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">また事前課題がございます。事前課題に対する検討結果を提出していただくことが参加条件となりますので、あらかじめご了解の上お申込ください。</span><span style="mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">お申込方法:</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://echo4.bluehornet.com/ct/24923673:23996494750:m:1:1378935879:C507F4AB26EDE8B585DF5F4A7BCE71EB:r"><span style="font-family: "MS Gothic"; mso-bidi-font-family: "MS Gothic";"><span style="color: #003591;">こちらの申込書</span></span></a></span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">に必要事項をご記入の上、</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">FAX</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">(</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">03-3583-1200</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">)またはメール添付</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">(<a href="mailto:diajapan@diajapan.org"><span style="color: #003591;">diajapan@diajapan.org</span></a>)</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">にてお申し込みください。</span><o:p></o:p><br />
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><img align="" border="0" height="11" id="_x0000_i1028" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" width="10" /> <a href="http://echo4.bluehornet.com/ct/24923673:23996494750:m:1:1378935879:C507F4AB26EDE8B585DF5F4A7BCE71EB:r"><span style="font-family: "MS Gothic"; mso-bidi-font-family: "MS Gothic";"><span style="color: #003591;">プログラム詳細/申込書はこちら</span></span></a><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">なお、本トレーニングは第</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">10</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">回</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"> DIA </span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">日本年会の初日に、同じ会場(</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;">TFT</span><span style="color: #5f6168; font-family: "MS Gothic"; font-size: 9pt; mso-bidi-font-family: "MS Gothic";">東京ファッションタウンビル)にて開催されます。<u>日本年会にもお申込される方には当コースの割引がございます。</u>皆様には、ぜひ日本年会とあわせ、本トレーニングにご参加いただきますよう、お願い申し上げます。</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><o:p></o:p></span></div>
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt;"><img align="" border="0" height="11" id="_x0000_i1029" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" width="10" /><span> </span><a href="http://echo4.bluehornet.com/ct/24923674:23996494750:m:1:1378935879:C507F4AB26EDE8B585DF5F4A7BCE71EB:r"><span style="color: #003591;"><span style="font-family: "MS Gothic"; mso-bidi-font-family: "MS Gothic";">第</span>10<span style="font-family: "MS Gothic"; mso-bidi-font-family: "MS Gothic";">回</span>DIA<span style="font-family: "MS Gothic"; mso-bidi-font-family: "MS Gothic";">日本年会プログラム</span></span></a>
<img align="" border="0" height="11" id="_x0000_i1030" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" width="10" /><span> </span><a href="http://echo4.bluehornet.com/ct/24923675:23996494750:m:1:1378935879:C507F4AB26EDE8B585DF5F4A7BCE71EB:r"><span style="font-family: "MS Gothic"; mso-bidi-font-family: "MS Gothic";"><span style="color: #003591;">オンライン申込</span></span></a><o:p></o:p></span></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-26472624552393959332013-09-26T06:27:00.000-07:002013-09-26T06:27:49.950-07:00Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now<div style="text-align: left;">
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Publications" coords="10, 5, 76, 38" href="http://echo4.bluehornet.com/ct/24872534:23987491084:m:1:1378935879:70674D5542CEDAE00AEF037D6915D8B5:r" shape="Rect"></area><area alt="Meetings & Trainings" coords="113, 6, 176, 39" href="http://echo4.bluehornet.com/ct/24872535:23987491084:m:1:1378935879:70674D5542CEDAE00AEF037D6915D8B5:r" shape="Rect"></area><area alt="Speaking & Publishing" coords="216, 6, 283, 39" href="http://echo4.bluehornet.com/ct/24872536:23987491084:m:1:1378935879:70674D5542CEDAE00AEF037D6915D8B5:r" shape="Rect"></area><area alt="Networking & Communities" coords="324, 6, 399, 39" href="http://echo4.bluehornet.com/ct/24872537:23987491084:m:1:1378935879:70674D5542CEDAE00AEF037D6915D8B5:r" shape="Rect"></area><area alt="Exhibiting
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<div style="line-height: 16.8pt;">
<strong><span style="color: #00a84f; font-family: "Arial","sans-serif";">Essentials for Success! – Join DIA China Medical
Affairs and Medical Writing Training Now</span></strong><span style="color: #00a84f; font-family: "Arial","sans-serif";"><o:p></o:p></span></div>
<div style="line-height: 16.8pt; margin-bottom: 0pt;">
<span style="color: #00a84f; font-family: "Arial","sans-serif"; font-size: 10.5pt;">December
9-10, 2013 | Shanghai, China<o:p></o:p></span></div>
<div style="line-height: 14.4pt; margin-bottom: 0pt;">
<span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 10pt;">With
the changes in local and global environments and requirements for
compliance in the healthcare, more challenges are expected for the
professionals working in the medical affairs and medical
communication communities. The course, which is designed based on
adult learning principles, evidence and rich experience, will provide
highly interactive opportunities for participants to learn. The
course will benefit professionals by providing knowledge, experience,
and tools to better navigate ways through the challenges associated
with communication and trusted relationships development with
external and internal customers.<o:p></o:p></span></div>
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<div style="line-height: 16.8pt;">
<strong><span style="color: #00a84f; font-family: "Arial","sans-serif";">Who Should Attend</span></strong><span style="color: #00a84f; font-family: "Arial","sans-serif";"><o:p></o:p></span></div>
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<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 3.75pt 0in 0in; width: 12pt;" valign="top" width="16">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Medical
Affairs<o:p></o:p></span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 1;">
<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 3.75pt 0in 0in; width: 12pt;" valign="top" width="16">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><img align="" border="0" id="_x0000_i1029" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/CH_triangle_mini.gif" /><o:p></o:p></span></div>
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<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 0in 7.5pt;">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Medical/Scientific
Writing<o:p></o:p></span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 2;">
<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 3.75pt 0in 0in; width: 12pt;" valign="top" width="16">
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><img align="" border="0" id="_x0000_i1030" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/CH_triangle_mini.gif" /><o:p></o:p></span></div>
</td>
<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 0in 7.5pt;">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Clinical
Research & Development<o:p></o:p></span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 3;">
<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 3.75pt 0in 0in; width: 12pt;" valign="top" width="16">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><img align="" border="0" id="_x0000_i1031" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/CH_triangle_mini.gif" /><o:p></o:p></span></div>
</td>
<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 0in 7.5pt;">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Medical
Communications/Information<o:p></o:p></span></div>
</td>
</tr>
<tr style="mso-yfti-irow: 4; mso-yfti-lastrow: yes;">
<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 3.75pt 0in 0in; width: 12pt;" valign="top" width="16">
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<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><img align="" border="0" id="_x0000_i1032" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/CH_triangle_mini.gif" /><o:p></o:p></span></div>
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<td style="background-color: transparent; border: rgb(0, 0, 0); padding: 0in 0in 7.5pt;">
<div class="MsoNormal" style="margin: 0in 0in 0pt;">
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Professional
Development<o:p></o:p></span></div>
</td>
</tr>
</tbody></table>
</td>
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<span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 10pt;"><a href="http://echo4.bluehornet.com/ct/24872520:23987491084:m:1:1378935879:70674D5542CEDAE00AEF037D6915D8B5:r"><span style="font-size: 9pt;"><span style="color: #003591;">Download the Program</span></span></a><o:p></o:p></span></div>
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<span style="mso-fareast-font-family: "Times New Roman";"> <o:p></o:p></span></div>
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<span style="color: white; font-family: "Arial","sans-serif"; font-size: 10.5pt; mso-fareast-font-family: "Times New Roman";">Main
Instructors</span><span style="color: white; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<b><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 9pt;">Min IRWIN, MD, PhD</span></b><span style="color: #5e6167; font-family: "Arial","sans-serif";"><br />
</span><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 8.5pt;">Vice President, <br />
Medicines Development, GlaxoSmithKline, China</span><br />
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<b><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 9pt;">Karen WOOLLEY, PhD</span></b><span style="color: #5e6167; font-family: "Arial","sans-serif";"><br />
</span><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 8.5pt;">CEO, ProScribe Medical Communications, China, Japan
& Australia<br />
Professor, University of Queensland and University of the Sunshine
Coast, Australia</span><br />
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<td style="background-color: transparent; border: rgb(0, 0, 0); height: 71.25pt; padding: 3.75pt;" valign="top">
<b><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 9pt;">Julie MONK, PhD</span></b><span style="color: #5e6167; font-family: "Arial","sans-serif";"><br />
</span><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 8.5pt;">Medical Writer, <br />
ProScribe Medical Communications, China, Japan & Australia</span><br />
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<strong><span style="color: #00a84f; font-family: "Arial","sans-serif";">DIA China Member Online Management</span></strong><span style="color: #00a84f; font-family: "Arial","sans-serif"; font-size: 13.5pt;"><o:p></o:p></span></div>
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<span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 9pt;">Dear
Member<o:p></o:p></span></div>
<div style="line-height: 14.4pt; margin-bottom: 0pt;">
<span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 9pt;">DIA
China Member Management is now online. You can log in DIA China website
at <a href="http://echo4.bluehornet.com/ct/24872524:23987491084:m:1:1378935879:70674D5542CEDAE00AEF037D6915D8B5:r"><span style="color: #003591;">www.diachina.org</span></a>
to view and manage your data for receiving the latest international
pharmaceutical information.</span><span style="color: #5e6167; font-family: "Arial","sans-serif"; font-size: 10pt;"><o:p></o:p></span></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-48194435469420329482013-09-25T07:33:00.000-07:002013-09-25T07:33:37.014-07:00Meet to Focus on Rare Diseases & Orphan Product Research, Development, and Access <div style="text-align: left;">
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<td align="left" bgcolor="#b6b1a9" valign="middle"><a href="http://echo4.bluehornet.com/ct/24809487:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E"><img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_13017_600x150.gif" style="margin: 0px;" /></a></td></tr>
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</td></tr>
<tr>
<td align="center" bgcolor="#ffffff" valign="top"><img alt="" border="0" height="47" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-nav-menu.jpg" style="margin: 0px;" usemap="#Map2" width="600" /></td></tr>
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<div style="color: #003591; font-size: 28px; line-height: 30px;">
<span style="color: #336699;"><span style="font-size: 22px;"><strong>Meet to Focus on
Rare Diseases & Orphan Product Research, Development, and Access
</strong></span></span></div>
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<div style="text-align: center;">
<span style="color: #336699;"><strong>Mobile App
Now Available</strong></span><a href="http://echo4.bluehornet.com/ct/24809488:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Click</a>
to download today.</div>
<div style="text-align: center;">
<a href="http://echo4.bluehornet.com/ct/24809488:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E"><img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_13017_ipad.jpg" style="margin: 0px;" /></a></div>
<img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_13017_120x240_Themes.gif" style="margin: 0px;" /><br />
<a href="http://echo4.bluehornet.com/ct/24809489:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E"><img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/generic_exhibiting_box_120x240.gif" style="margin: 0px;" /></a></td></tr>
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<a href="http://echo4.bluehornet.com/ct/24809487:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E"><strong>US
Conference on Rare Diseases & Orphan Products: <br />The New Era in Health
Care</strong></a><br />October 7-9 | North Bethesda, MD<br /><strong>Co-sponsored
with National Organization for Rare Disorders</strong><br />
<span style="color: #336699;"><strong>Overview:</strong></span><br />
At this annual conference, all stakeholders in the rare disease/orphan
product community - patients, patient organizations, researchers, drug and
device companies, investors, thought leaders and government – meet to focus on
rare diseases and orphan product research, development, and access. <a href="http://echo4.bluehornet.com/ct/24809490:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E"><strong>Search
the Online Program</strong></a>.<br />
<span style="color: #336699;"><strong>Keynote Speaker:</strong></span><br />
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<td>
<img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/Corr_Bill_45x55.jpg" style="margin: 0px;" /></td></tr>
</tbody></table>
<strong>Bill Corr</strong><br />Deputy Secretary<br />U.S. Department of Health
and Human Services<br />
<span style="color: #336699;"><strong>Luncheon
Speaker:</strong></span><br />
<a href="http://echo4.bluehornet.com/ct/24809491:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">FDA
Initiatives on Orphan Products</a><br />Monday, October 7 | 11:45AM-1:00PM<br />
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<strong>Janet Woodcock, MD</strong><br />Director, Center for Drug Evaluation
and Research (CDER)<br />FDA<br />
<span style="color: #336699;"><strong>Plenary Sessions:</strong></span><br />
• <a href="http://echo4.bluehornet.com/ct/24809492:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">The
Affordable Care Act and the Rare Diseases Community</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809493:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Plenary
Session 2:</a><br /> - NINDS NeuroNext Program<br /> - NORD
Initiative on Natural History Studies<br /> • <a href="http://echo4.bluehornet.com/ct/24809494:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Health
Care System of the Future</a> • <a href="http://echo4.bluehornet.com/ct/24809495:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Research
Frontiers in Rare Diseases: The Next Opportunities</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809496:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">The
Next 30 Years</a>
<span style="color: #336699;"><strong>Session Topics:</strong></span><br />
• <a href="http://echo4.bluehornet.com/ct/24809497:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Patients
and Industry: Partnership and Collaboration in Research </a><br /> <a href="http://echo4.bluehornet.com/ct/24809497:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Funding
and FDA Review</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809498:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">The
Investment Environment for Orphan Drugs/Devices</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809499:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">FDA's
Orphan Grants Program</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809500:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">FDASIA
Provision Highlights</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809501:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Collaboration
from Bench to Bedside: How Industry and Patients </a><br /> <a href="http://echo4.bluehornet.com/ct/24809501:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Can
Partner in Rare Diseases</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809502:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Hearing
the Voice of the Patient</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809503:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">The
International Perspective on Orphan Drug/Devices</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809504:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Assuring
Patient Access to Treatments</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809505:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Paying
for Orphan Therapies</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809506:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Repurposing:
FDA and NIH Perspectives</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809507:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Managing
Orphan Drug Recalls and Shortages</a><br /> • <a href="http://echo4.bluehornet.com/ct/24809508:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">NIH
Clinical Center-CDER Clinical Trials and Regulatory </a><br /> <a href="http://echo4.bluehornet.com/ct/24809508:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Training
Collaborative</a><br /> • Plus More<span style="color: #336699;"><strong><br /></strong></span><br />
<span style="color: #336699;"><strong><img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/generic_new_27x27.jpg" style="margin: 0px;" />
Just Added: New Tutorial | October 6: </strong></span><br />
<a href="http://echo4.bluehornet.com/ct/24809509:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Overview
of The Regulatory Frameworks and Opportunities for Orphan Medicinal Products
(OMPs)</a><br />
The tutorial will describe regulatory frameworks from FDA and EMA and
incentives for development of Orphan Medicinal Products (OMPs). It will cover
details regarding incentives for developments of OMPs, opportunities and
challenges. Additionally, this tutorial will give an overview of the different
options to gather control data in rare/ultra rare disease settings. Case studies
for requests for ODDs and marketing authorizations for OMPs will be presented
and discussed.<br />
<div style="padding: 5px 0px; text-align: center;">
<img alt="" border="0" height="11" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" style="margin: 0px;" width="10" /> <a href="http://echo4.bluehornet.com/ct/24809487:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Overview</a>
| <a href="http://echo4.bluehornet.com/ct/24809510:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Agenda</a>
| <a href="http://echo4.bluehornet.com/ct/24809511:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Register
Now</a><em><br /></em></div>
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<div style="color: #003591; font-size: 18px;">
<span style="font-size: 18px;"><span style="color: #336699;">Move Toward Better Communication and Collaboration Among
Patients, Payers, and Product Developers </span></span><span style="color: #336699;"><br /></span></div>
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<td align="left" height="100" valign="top"><img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_13027_135x105.gif" style="margin: 0px;" /></td></tr>
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<strong><a href="http://echo4.bluehornet.com/ct/24809514:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">A
Model of Patient, Payer, and Product Developer Collaboration to Support
Innovating for Value</a></strong>October 30-31 | Washington,
DC<strong><br /></strong><br />
DIA and the Brookings Institution are collaborating to strengthen
communication between health care stakeholder communities. This conference will
focus on highlighting the perspectives and outcomes most relevant to patient
communities, reimbursement requirements and innovative payment models of most
interest for payer groups, and how both can help inform product developers as
they drive toward novel value-based innovation. <strong>Register by October 9 to
Save $100!</strong><br />
<span style="color: #336699;"><strong>Keynote Speaker:
</strong></span><br />
<strong>James Heywood </strong><br />Co-Founder, Chairman
<br />PatientsLikeMe<br />
<span style="color: #336699;"><strong>Session Topics:</strong></span><br />
• Aligning Perspectives on Value and Outcomes<br /> • Identifying Stakeholder
Needs and Challenges to <br /> Strategic Communication<br /> • Exploring
Opportunities for Efficient Engagement <br /> Throughout Discovery, Clinical
Development, Regulatory <br /> Review, and Product Use<br /> • Case
Studies and Current Initiatives<br /> • Next Steps: Charting a Course
Forward<br /> • And More<br />
<div align="right" style="padding: 5px 0px;">
<img alt="" border="0" height="11" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" style="margin: 0px;" width="10" /> <a href="http://echo4.bluehornet.com/ct/24809514:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Overview</a>
| <a href="http://echo4.bluehornet.com/ct/24809515:23981326351:m:N:1378935879:03BDEA471675CFFF235233B190F28A2E">Register
Online</a></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-5921458952688633992013-09-25T06:01:00.000-07:002013-09-25T07:28:47.380-07:00第10回DIA 日本年会では<div style="text-align: left;">
<a href="http://www.diahome.org/Tools/Content.aspx?type=eopdf&file=%2fproductfiles%2f2610177%2f13303%2Epdf" target="_blank" title="新規ウィンドウで開きます:イベントの詳細へ"><img alt="第10回 DIA日本年会 日本発の創薬革命~ 革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割 ~【日時】2013年11月6日(水)~8日(金)【場所】TFT東京ファッションタウンビル(有明)" height="168" src="http://www.diajapan.org/meetings/13303/img/header.jpg" width="640" /></a><br />
<br />
DIA日本年会は、医薬品を始めとする医療用製品の開発やライフサイクルマネジメントに関するグローバルな最新のトピックを取り上げ、国内外の企業・アカデミア・規制当局が一堂に会し、オープンに意見交換・議論を行うする国内最大規模の会議です。<br />
<br />
第10回DIA 日本年会では、委員長に千葉大学学長 齋藤 康先生をお迎えし、「日本発の創薬革命 ~ 革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割 ~」をテーマに、創薬・育薬に果たす企業・アカデミア・行政の役割をさまざまな角度から議論します。プログラムは3日間6トラックで進行し、薬事、臨床開発、安全性、統計・DM、PM、CMC、シックスシグマ、HTA、患者会などの領域に関連した数多くのセッションが企画されています。<br />
<br />
<a href="http://www.diajapan.org/meetings/13303/">http://www.diajapan.org/meetings/13303/</a><br />
<br />
<br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-55100942944549397672013-09-23T06:25:00.000-07:002013-09-23T06:25:46.270-07:00Clinical Project Management Training course Mexico City on November 7<div style="text-align: left;">
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<div style="color: #003591; font-size: 28px; line-height: 30px;">
<span style="color: #33ccff;"><span style="font-size: 22px;"><strong>Get the Latest
Expert Advice in Managing a Clinical Trial </strong></span></span><span style="color: #009b3a;"><span style="font-size: 22px;"><strong><br /></strong></span></span></div>
There’s just one month to go until the <a href="http://echo4.bluehornet.com/ct/24737723:23960150849:m:N:1378935879:9D4BF27DDEFBB2AE44BD1AECACC97AE5">Clinical
Project Management Training</a> course, to be held in Mexico City, Mexico on
November 7.<br />
Attend this training course to learn how to define the scope of
interventional and observational clinical studies, evaluate the main
requirements, and identify suppliers for the feasible conduction of a clinical
trial. Participants will also develop an understanding of the global regulatory
framework and its application to accomplish a successful clinical study.<br />
<div style="text-align: right;">
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out More</a><span style="font-size: 12px;"> <img alt="" border="0" height="11" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" style="margin: 0px;" width="10" /> <a href="http://echo4.bluehornet.com/ct/24737724:23960150849:m:N:1378935879:9D4BF27DDEFBB2AE44BD1AECACC97AE5">Download
Program</a> </span><img alt="" border="0" height="11" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/template-bullet.gif" style="margin: 0px;" width="10" /> <a href="http://echo4.bluehornet.com/ct/24737724:23960150849:m:N:1378935879:9D4BF27DDEFBB2AE44BD1AECACC97AE5">Register</a></div>
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<li>Global Regulatory Framework
<li>Clinical Studies in Latin America
<li>Role of the Study Manager
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<li>Clinical Data Management
<li>Safety</li>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-34612530640212883422013-09-20T05:35:00.004-07:002013-09-25T07:29:38.262-07:00第10回 DIA日本年会<div style="text-align: left;">
<span style="font-size: large;">第10回 DIA日本年会</span><br />
<span style="font-size: large;">日本発の創薬革命</span><br />
<span style="font-size: large;">~ 革新的創薬・育薬に向けた アカデミア・行政・企業の果たすべき役割 ~</span><br />
<span style="font-size: large;">2013年11月6日(水)~8日(金)</span><br />
<span style="font-size: large;">TFT東京ファッションタウンビル(有明)</span><br />
<br />
<div style="text-align: left;">
</div>
<div style="text-align: left;">
新薬の開発には膨大な時間と開発費用が必要であるにも関わらず、新規化合物</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
が臨床開発を経て、医薬品として承認される成功確率は数万分の1とも言われ、</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
その困難さは今後も増大するものと予想されています。海外に目を向けますと、</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
米国NIHに代表されるように、国を挙げて化合物スクリーニングや化合物ライブラ</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
リーの構築を進めています。</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
我が国においても、早期開発の重要性が指摘されており、特にアカデミアやベン</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
チャー企業により発見された有望な新規化合物の医薬品開発は喫緊の課題で</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
す。平成</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
<span style="font-family: GothamNarrow-Book;"><span style="font-family: GothamNarrow-Book;">23</span></span><span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;">年には、PMDAにおいて薬事戦略相談制度が導入されアカデミア等に</span></span></div>
<div style="text-align: left;">
<span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;"></span></span><br /></div>
<span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;"><div style="text-align: left;">
対する支援体制がスタートしました。また、早期・探索的臨床試験拠点や臨床研</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
究中核病院の整備も進んでおり、革新的医薬品/医療機器の開発を推進するこ</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
とが期待されます。しかしながら、アカデミア、行政、企業、さらには患者さんの視</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
点も加わった連携の中で日本発医薬品/医療機器の開発がなされるには未だ</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
多くの課題を抱えています。</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
そこで、本年会ではアカデミア、行政、企業、患者さんが一体となって革新的医薬</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
品の創薬・育薬を進めていくには何をすべきかを中心に議論を行います。AROな</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
ど医療機関に関係するセッションや、コンパニオン診断薬の問題と解決策など、</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
医療現場においても有用なセッションを用意しています。医薬品開発の国際化が</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
加速する中で、日本は何をすべきかをアカデミア、臨床、プロジェクトマネジメン</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
ト、薬事等の視点から広範囲な議論を行います。薬事法やGCPの改正をはじめと</div>
<div style="text-align: left;">
<br /></div>
<div style="text-align: left;">
する幅広い最新情報を提供するために、本年も</div>
</span><div style="text-align: left;">
<br /></div>
</span><br />
<div style="text-align: left;">
<span style="font-family: GothamNarrow-Book;"><span style="font-family: GothamNarrow-Book;">6</span></span><span lang="JA" style="font-family: MS-PGothic;"><span lang="JA" style="font-family: MS-PGothic;">Trackによる進行とし、多数のセ</span></span></div>
<div style="text-align: left;">
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span style="font-size: small;"></span></span></span><br /></div>
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><div style="text-align: left;">
<span style="font-size: small;">ッションを開催します。</span></div>
<div style="text-align: left;">
<span style="font-size: small;"></span><br /></div>
<div style="text-align: left;">
<span style="font-size: small;">また、今年の年会の大きな特色として、ICH大阪会議の直前に開催されることか</span></div>
<div style="text-align: left;">
<span style="font-size: small;"></span><br /></div>
<div style="text-align: left;">
<span style="font-size: small;">ら、多くのICH関係者が演者もしくはパネリストとして参加を予定しています。医薬</span></div>
<div style="text-align: left;">
<span style="font-size: small;"></span><br /></div>
<div style="text-align: left;">
<span style="font-size: small;">品開発に関わる方々にとって、有益な情報交換の場となるものと思いますので、</span></div>
<div style="text-align: left;">
<span style="font-size: small;"></span><br /></div>
<div style="text-align: left;">
<span style="font-size: small;">一人でも多くの皆様のご参加をお待ちしています。</span></div>
<div style="text-align: left;">
<span style="font-size: small;"></span> </div>
<div style="text-align: left;">
<span style="font-size: small;"></span> </div>
<div style="text-align: left;">
<span style="font-size: small;"></span> </div>
<b><span lang="JA" style="color: #00549f; font-family: KozGoPro-Bold; font-size: xx-small;"><span lang="JA" style="color: #00549f; font-family: KozGoPro-Bold; font-size: xx-small;"><span lang="JA" style="color: #00549f; font-family: KozGoPro-Bold; font-size: xx-small;"><div style="text-align: left;">
<span style="font-size: small;">後援予定:厚生労働省/独立行政法人医薬品医療機器総合機構/</span></div>
<span style="font-size: small;">
</span><div style="text-align: left;">
<span style="font-size: small;"></span><br /></div>
<span style="font-size: small;">
</span><div style="text-align: left;">
<span style="font-size: small;"> 日本製薬工業協会/米国研究製薬工業協会</span><br />
<span style="font-size: large;"></span><br />
<span style="font-size: large;"></span><br />
<br />
<span style="font-size: small;">展示申込受付中<br />詳細については、下記までお問い合わせください。 一般社団法人ディー・アイ・エー・ジャパン</span><br />
<span style="font-size: small;">〒106-0041 東京都港区麻布台1-11-10 日総第22ビル7F Tel: 03-5575-2130<br />Fax: 03-3583-1200<br />email: </span><a href="mailto:diajapan@diajapan.org"><span style="font-size: small;">diajapan@diajapan.org</span></a></div>
</span></span></span></b></span></span><br />
<br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-87203121028401754032013-09-20T05:32:00.002-07:002013-09-25T07:30:56.578-07:00第10回 DIA 日本年会プログラムがウェブサイトで公開されました<div style="text-align: left;">
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<td align="left" bgcolor="#b6b1a9" valign="middle"><a href="http://www.diahome.org/Tools/Content.aspx?type=eopdf&file=%2fproductfiles%2f2610177%2f13303%2Epdf" target="_blank" title="新規ウィンドウで開きます:イベントの詳細へ"><img alt="第10回 DIA日本年会 日本発の創薬革命~ 革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割 ~【日時】2013年11月6日(水)~8日(金)【場所】TFT東京ファッションタウンビル(有明)" height="168" src="http://www.diajapan.org/meetings/13303/img/header.jpg" width="640" /></a></td></tr>
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<td align="left" style="padding: 14px 14px 20px;" valign="top">第10回 DIA日本年会<br />
日本発の創薬革命<br />
~ 革新的創薬・育薬に向けた アカデミア・行政・企業の果たすべき役割 ~<br />
2013年11月6日(水)~8日(金)<br />
TFT東京ファッションタウンビル(有明)<br />
<br />
<span style="color: #003591;"><span style="font-size: 22px; line-height: 30px;"><strong>第10回DIA日本年会プログラムがウェブサイトで公開されました!</strong></span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">今年の日本年会は、委員長に千葉大学学長 齋藤
康先生をお迎えし、「日本発の創薬革命 ~ 革新的創薬・育薬に向けたアカデミア・行政・企業の果たすべき役割 ~」をテーマに、3日間6トラックのプログラム構成で臨床
/ 薬事 / 統計 / 安全性 / プロジェクトマネジメント / データマネジメント / CMC / メディカルライティング / シックシグマ / HTA /
患者会等の各領域に関連した数多くセッションが企画されています。また、年会のオープニングに先立ち、初日の午前中にはチュートリアルセッションとスチューデント
セッションも設けております。</span></span><br />
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">今年の大きな特色の一つとして、ICH大阪会議の直前に開催されることから、海外規制当局の方々を初めとする多くのICH関係者が、演者もしくはパネリストとしてご参加される予定です。</span></span><br />
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<span style="font-size: 16px;"><strong><span style="color: #003591;">出展及び特別協賛のご案内</span></strong></span></div>
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif;"><span style="font-size: 12px; line-height: 18px;">本年会では、展示に於きましても新しい企画を試みており、約900平米という大きな展示スペースを活かし、ランチタイムやコーヒーブレイクタイムでの企業によるプレゼンテーションなど、これまでとは違った本格的展示企画をご用意しております。</span></span><br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-18160352005436416872013-09-17T12:43:00.000-07:002013-09-17T12:49:15.502-07:00DIA's 8th Annual Conference - The New Clinical Research Environment in India<div style="text-align: left;">
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<td align="left" bgcolor="#b6b1a9" valign="middle"><img alt="8th Annual Conference | The New Clinical Research Environment in India: Implications and Opportunities | October 24-26 | Bangalore, India" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/13659_EmailHeader_600x150.gif" style="margin: 0px;" title="" /></td></tr>
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<span style="color: #d52b1e;"><span style="font-size: 22px;"><strong><a href="http://bit.ly/DIA-India13659">Join Prominent Professionals to Discuss the Changing Industry</a></strong></span></span><span style="font-size: 22px;"><strong><br /></strong></span></div>
Join academia, industry, regulators and researchers to discuss the new
environment for health care product development at DIA India’s <a href="http://echo4.bluehornet.com/ct/24217581:23860158638:m:N:1378935879:ACC928880592ADD3E7AF8F62519C6C95">8th
Annual Conference</a>.<br />
The event, to be held in Bangalore from October 24 to 26, will provide a
forum for professionals to hear how their peers are coping with the challenges
of new regulations and how they are planning to realize the promise of emerging
opportunities.<br />
More than 90 renowned experts will speak on key issues, including keynote
presenters Prof. Ranjit Roychaudhuory, Chairman of the Task Force for Research
at Appollo Hospitals Group, and Mukhtar Ahmed, Oracle HSGBU’s Vice President of
Product Strategy.<br />
The conference will also feature 12 tracks with 48 sessions
on the key themes of clinical research, IT, life sciences, medical writing, and
biostatistics.<br />
Program highlights include:<br />
<ul>
<li>Direction, outlook and vision for health related research in India
<li>Review of recent changes in regulations and their implications
<li>Challenges to global development and commercialization ex-India
<li>New opportunities for India-centric global delivery solutions
<li>Global benchmarks in health care research regulations
<li>Patient-centric endeavors for awareness and ethics of research
</li>
</li>
</li>
</li>
</li>
</li>
</ul>
<span style="color: #d52b1e;"><strong>Exhibiting and Support
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<span style="color: #d52b1e;">upcoming events</span></div>
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<a flagship-meetings="" href="http://echo4.bluehornet.com/ct/24217585:23860158638:m:N:1378935879:ACC928880592ADD3E7AF8F62519C6C95" rarediseases2013.aspx="" target="<not set>"><img alt="US Conference on Rare Diseases & Orphan Products" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/NA_13017_120x240_EB.gif" style="margin: 0px;" /></a><strong><br /></strong></div>
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<span style="color: #d52b1e;">THANK YOU <br />TO OUR MEDIA <br />PARTNERS</span></div>
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<span style="color: #d52b1e;">Keynote
Speakers</span></div>
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<td style="text-align: center;"><img alt="Ranjit Roy Chaudhury" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/13659-chaudhury-ranjit-100x100.gif" style="margin: 0px;" /></td>
<td style="text-align: center;"><img alt="Mukhtar Ahmed" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/13659-ahmed-mukhtar-100x100.gif" style="margin: 0px;" /></td></tr>
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<td style="text-align: center;" valign="top"><span style="color: #5f6168;"><strong><span style="font-size: 12px;"><span style="font-family: Arial;">Padmashree <br />Ranjit Roy
Chaudhury</span></span></strong><span style="font-size: 12px;"><span style="font-family: Arial;"><br />Apollo Hospitals Group</span></span></span></td>
<td style="text-align: center;" valign="top"><span style="color: #5f6168;"><strong><span style="font-size: 12px;"><span style="font-family: Arial;">Mukhtar Ahmed</span></span></strong><br /><span style="color: #5f6168;"><span style="font-size: 12px;"><span style="font-family: Arial;">Oracle
HSGBU</span></span></span></span></td></tr>
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<div style="color: #003591; font-size: 18px;">
<span style="color: #d52b1e;">Featured
Topics</span></div>
<ul>
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<li>Development
<li>Manufacturing
<li>Commercialization
<li>Regulatory
<li>Ethical, Social, Legal, Technology & Standards
<li>Lean Strategy
<li>Outsourcing Strategy
<li>Pharmacovigilance
<li>Therapeutics </li>
</li>
</li>
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</li>
</ul>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-27514807661357304132013-09-17T05:08:00.000-07:002013-09-17T05:08:59.193-07:006th DIA China Annual Meeting - Save the Date!<div style="text-align: left;">
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<h1 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 22px; margin-bottom: 2px; margin-top: 25px;">
6th
DIA China Annual Meeting</h1>
<div class="p2" style="color: #6c2d60; font-family: Arial, Helvetica, sans-serif; font-size: 13px; line-height: 1.5em; margin-top: 10px;">
May 11, 2014: Pre-conference Workshops<br />May 12-14, 2014: Conference,
Exhibition and Posters<br /><strong>Shanghai International Convention Center
(SHICC), China</strong></div>
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<h4 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 14px; font-weight: bold; margin-top: 18px;">
Delegate
Participation Profile at 5th DIA China Annual Meeting<br /><br /><img alt="" border="0" src="http://echo4.bluehornet.com/cimages/3e5f25bb03aa082389f3e25d9004bb6e/CH_14975_Delegate-Participation-Profile-at-5th-DIA-China-Annual-Meeting.gif" style="margin: 0px;" /></h4>
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<h3 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 16px; font-weight: bold; margin-bottom: 6px; margin-top: 18px;">
Showcase
Your Products and Services!</h3>
<div class="p2" style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 1.5em; margin-top: 2px;">
<em>Want to select a good booth location and maximize your exposure at
6th DIA China Annual Meeting? Make your reservation today!</em></div>
<h3 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 12px; font-weight: bold; margin-bottom: 6px; margin-top: 12px;">
Exhibition:
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; line-height: 1.5em; margin-top: 2px;">Three
classes of 3M x 3M booths are available based on booth location: <br /><a href="http://echo4.bluehornet.com/ct/24440944:23903513363:m:N:1378935879:87AF8FAB8A005D8AAD0F99F5A39E5FB3">Floor
Plan</a> <a href="http://echo4.bluehornet.com/ct/24440945:23903513363:m:N:1378935879:87AF8FAB8A005D8AAD0F99F5A39E5FB3">Application
Form_EN</a> <a href="http://echo4.bluehornet.com/ct/24440946:23903513363:m:N:1378935879:87AF8FAB8A005D8AAD0F99F5A39E5FB3">Application
Form_CN</a></span></h3>
<table border="0" cellpadding="0" cellspacing="0" style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; line-height: 1.5em; margin-top: 2px;">
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<strong>Booth Size </strong></td>
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<strong>Price (RMB)</strong></td></tr>
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3M X 3M Class I</td>
<td valign="top" width="178">
41,000</td></tr>
<tr>
<td valign="top" width="178">
3M X 3M Class II<br />3M X 3M Class III</td>
<td valign="top" width="178">
38,000<br />36,000</td></tr>
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<h3 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 12px; font-weight: bold; margin-bottom: 6px; margin-top: 15px;">
<br />Advertising:
<span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; line-height: 1.5em; margin-top: 2px;"><a href="http://echo4.bluehornet.com/ct/24440947:23903513363:m:N:1378935879:87AF8FAB8A005D8AAD0F99F5A39E5FB3">Application
Form_EN</a> <a href="http://echo4.bluehornet.com/ct/24440948:23903513363:m:N:1378935879:87AF8FAB8A005D8AAD0F99F5A39E5FB3">Application
Form_CN</a></span></h3>
<table border="0" cellpadding="0" cellspacing="0" style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; line-height: 1.5em; margin-top: 2px;">
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<strong>Type (CMYK)</strong></td>
<td valign="top" width="178">
<strong>Price (RMB)</strong></td></tr>
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<td valign="top" width="178">
Full Page</td>
<td valign="top" width="178">
10,000</td></tr>
<tr>
<td valign="top" width="178">
Half Page</td>
<td valign="top" width="178">
5,000</td></tr>
<tr>
<td valign="top" width="178">
Centerfold/Center Spread</td>
<td valign="top" width="178">
18,000</td></tr>
<tr>
<td valign="top" width="178">
Inside Front Cover</td>
<td valign="top" width="178">
15,000</td></tr>
<tr>
<td valign="top" width="178">
Inside Back Cover</td>
<td valign="top" width="178">
15,000</td></tr>
</tbody></table>
<h3 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 12px; font-weight: bold; margin-bottom: 6px; margin-top: 15px;">
<br />Hosting
Opportunities: <span style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; font-weight: normal; line-height: 1.5em; margin-top: 2px;"><a href="http://echo4.bluehornet.com/ct/24440949:23903513363:m:N:1378935879:87AF8FAB8A005D8AAD0F99F5A39E5FB3">Application
Form</a></span></h3>
<div class="p2" style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 1.3em; margin-top: 2px;">
In addition to the Platinum, Gold and Silver support levels, additional
hosting opportunities include a networking reception, VIP dinner, tea break,
lunch and internet booth.</div>
<h3 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 12px; font-weight: bold; margin-bottom: 6px; margin-top: 15px;">
NEW! </h3>
<div class="p2" style="color: #5f6168; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 1.3em; margin-top: 2px;">
6th DIA China annual meeting also provides new hosting opportunities,
such as attendee bag insert, hanging banners, and carpet clings offering unique
levels of exposure for your company!</div>
<h3 style="color: #6c2d60; font-family: Arial,Helvetica; font-size: 11px; font-weight: bold; margin-bottom: 6px; margin-top: 15px;">
For
more information, please contact Jean Xu at <a href="mailto:jxu@kellencompany.com">jxu@kellencompany.com</a>, Sofie Peeters at
<a href="mailto:speeters@kellencompany.com">speeters@kellencompany.com</a>, or
call +86 10 5923
1096</h3>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-7293471246951553082013-09-16T05:59:00.000-07:002013-09-16T06:03:30.830-07:00DIA Content Currents: EDITION PUBLISHED: September 6, 2013<div style="text-align: left;">
<div class="hgroup clearfix">
<h1>
<a href="http://bit.ly/DIAContentCurrents">Content Currents</a></h1>
<br /></div>
<a href="http://bit.ly/DIAContentCurrents"><img alt="DIA" src="http://www.diahome.org/~/~/media/News-and-Publications/DIA-Cover-133x170.ashx" style="float: left; margin-bottom: 10px; margin-right: 10px;" /></a><br />
DIA's<em> Content Currents</em> provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development. <a href="http://bit.ly/DIAContentCurrents">Start each week off by visiting DIA's <em>Content Currents</em>.</a> <br />
<br />
<em>EDITION PUBLISHED: September 6, 2013</em><br />
<strong>SECTION 1 FDA GUIDANCES</strong><br />
August 26, 2013, FDA released a draft guidance for industry entitled, <strong>“ANDAs: Stability Testing of Drug Substances and Products; Questions and Answers,”</strong> which provides answers to questions received during the public comment period for this draft guidance document originally published on September 25, 2012. The draft guidance addresses issues related to drug master files, drug product manufacturing and packaging, stability studies, amongst others in order to provide clarification on the recommendations for stability testing data for ANDAs. [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM366082.pdf" target="_blank">Draft Guidance</a>] (FDA.gov)<br />
<br />
August 27, 2013, FDA released a guidance on <strong>“Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed”.</strong> This guidance is is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in fulfilling responsibilities related to reviewing the qualifications of investigators and adequacy of research sites, and determining whether an investigational new drug (IND) application or investigational device exemption (IDE) is required, to protect the rights and welfare of human subjects involved in biomedical research. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-27/html/2013-20822.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery" target="_blank">Federal Register</a>]<br />
<br />
August 28, 2013, FDA released a draft guidance on <strong>“The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers.”</strong> This draft guidance answers commonly asked questions about the applicability of good laboratory practice (GLP) to nonclinical laboratory studies conducted in support of research and marketing applications for medical devices. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-28/html/2013-20916.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery" target="_blank">Federal Register</a>]<br />
<br />
August 30, 2013, FDA released a draft guidance on <strong>“Select Updates for Non-Clinical engineering Tests and Recommended Labeling for intravascular Stents and Associated Delivery Systems.”</strong> This guidance is to inform the coronary and peripheral stent industry about selected updates to FDA's thinking regarding certain non-clinical testing for these devices. While FDA is considering more substantial updates, it is issuing this update on select sections in order to notify the industry in a timely manner of its revised recommendations. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-30/html/2013-21191.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery" target="_blank">Federal Register</a>]<br />
<br />
September 4, 2013, FDA announced the availability of a draft guidance document for industry entitled, <strong>“Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.”</strong> The draft guidance is intended to address provisions in sections 701 and 702 of FDASIA that direct the agency’s Secretary to specify the UFI system for registration of domestic and foreign drug establishments. [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM367199.pdf" target="_blank">Draft Guidance</a>] (FDA.gov)<br />
<br />
September 5, 2013, FDA announced the availability of a <strong>“Draft standard operating procedure (SOP) for Level 1, Immediately in Effect (IIE) Guidance Documents on Premarket Data Issues.”</strong> In the draft, CDRH outlines its process to clarify and more quickly inform stakeholders when it has changed its expectations relating to, or otherwise has new scientific information that could affect, data submitted as part of an Investigational Device Exemption (IDE), Premarket Notification (510(k)), Premarket Approval (PMA), or Humanitarian Device Exemption (HDE) submissions. [<a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259172.pdf" target="_blank">SOP</a>] [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-09-05/pdf/2013-21544.pdf" target="_blank">FR Notice</a>] (FDA.gov) (See related information in “FDA Notes” below)<br />
<hr />
<strong>SECTION 2 FDA NOTES</strong> <strong>& RELATED NEWS</strong><br />
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<strong><a href="http://drugwonks.com/blog/in-the-pag" target="_blank">FDA Establishes Program Alignment Group to Adapt to Rapid Changes in the Regulatory Environment</a></strong><br />
September 6, 2013, Janet Woodcock sent an email to CDER staff announcing the establishment of the Program Alignment Group (PAG). “In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). Comprised of senior Agency leaders, the PAG is charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives. This group of senior leaders will achieve this goal by working together to promote the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its mission.” More detail at link above. (Drugwonks.com)<br />
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<strong>Draft SOP on IIE Guidance Explained</strong><br />
In a new Federal Register posting focusing on CDRH, FDA acknowledges that when it releases a guidance document, that document may well reflect formal agency policy years after it is first put into informal practice at the review level. Due to agency resource restrictions, it may be a long process to get a guidance document, regulation or compliance policy guide published. In the meantime, industry may still be operating under an assumption that the status quo framework is still in effect, when in fact a more current one is the de facto standard.<br />
To bridge the gap between unstated official policy and the issuance of guidance to industry, rapid tools for communication, broader communication, and standards for communicating to specific subsets of manufacturers are desirable. Thus, FDA will begin to issue what it calls Level 1, IIE guidance documents "when prior public participation is not feasible or appropriate."<br />
Revising the 2011 draft SOP on “Notice to Industry” letters in response to industry concerns, FDA has released the new “Draft Standard Operating Procedure (SOP): Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues.” The documents will still be released through regular Federal Register postings but will not be subject to a comment process prior to implementation. Comments will be accepted for 60 days after the release and will be considered during development of the related guidance. (See link to draft guidance in Section 1 above.)<br />
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<strong>FDA has announced the appointment of Melinda Plaisier as permanent director of the Office of Regulatory Affairs, effective September 3, 2013.</strong> She has been serving as Acting Associate Commissioner for ORA since October of last year, when the position was vacated by Dara Corrigan. Plaisier will report to the Deputy Commissioner for Global Regulatory Operations and Policy (now vacant since the departure of Deborah Autor). (FDA.gov)<br />
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<strong><a href="http://www.elsevierbi.com/publications/the-pink-sheet/75/35/fda-flexible-with-accelerated-approval-evidence-analysis-finds?elsca2=rss&elsca1=pink" target="_blank">FDA Flexible with Accelerated Approval Evidence, Analysis Finds</a></strong><br />
Executive Summary: Attorneys Sasinowski and Varond write that in some cases weak clinical evidence on the surrogate endpoint was not a barrier, but strong findings on unmet need and rarity usually are necessary for accelerated approval.<br />
An analysis of some drugs that used the accelerated approval pathway found FDA is flexible in determining the scientific evidence needed, but also determined a strong showing among some regulatory factors likely is required. The analysis seemed to point out that an accelerated approval decision does not seem to hinge on one specific factor, although a strong performance among some may offer a better chance at success.<br />
Among the findings was that the agency increasingly has been flexible in the level of clinical evidence it has accepted showing an effect on the surrogate endpoint and clinical benefit. Full article at link above. (Pink Sheet)<br />
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<strong><a href="http://www.youtube.com/watch?source=govdelivery&utm_medium=email&utm_source=govdelivery&v=CjeG--ik_bw" target="_blank">What is Regulatory Science</a></strong><br />
The link above is for a short YouTube video featuring Margaret Hamburg and other FDA officials explaining what regulatory science is and why it’s important to the work of FDA and to the health and well-being of consumers. (FDA.gov)<br />
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<strong><a href="http://blogs.fda.gov/fdavoice/index.php/2013/08/considering-womens-needs-in-developing-medical-devices-heres-how/?source=govdelivery&utm_medium=email&utm_source=govdelivery" target="_blank">Considering Women's Needs in Developing Medical Devices: Here's "HoW"</a></strong><br />
Women differ from men in anatomy, physiology, risk factors and disease symptoms. They are also likely to use more medical devices over the course of their lives than do men.<br />
This month we published a snapshot of how FDA is doing with such efforts. A congressionally-required report (Section 907 of FDASIA) looked at the inclusion and analysis of women and other demographic subgroups in clinical studies supporting the approval of medical devices and other FDA-regulated medical products.<br />
One specific activity highlighted in the report was a workshop sponsored earlier this summer by CDRH to formally launch a new program designed to more closely look at medical device use and the health of women (HoW). The three main goals of HoW are to: Improve the availability, consistency and communication of information to patients and providers that is specific to women’s needs for the safe and effective use of medical devices. Address identified gaps and unmet needs through targeted resources. Foster the development of innovative strategies, technology and clinical study models.<br />
With the issuance of the 907 report and an accompanying docket to receive comments from the public, we hope to gain an even more in-depth understanding about demographic subgroups. The input we receive will become the starting point for developing an Action Plan, to be released next year. (FDA.gov)<br />
<strong><br /><a href="http://blogs.fda.gov/fdavoice/index.php/2013/08/fda-takes-step-to-encourage-pediatric-drug-studies/?source=govdelivery&utm_medium=email&utm_source=govdelivery" target="_blank">FDA Takes Step to Encourage Pediatric Drug Studies</a></strong><br />
In a recent FDA Voice blog, Dr. Lynne Yao, Associate Director, Pediatric and Maternal Health Staff in CDER, wrote that under the reauthorized Pediatric Research Equity Act (PREA), FDA can waive, defer, or grant extensions for deferred pediatric studies in certain circumstances. In the past, deadlines for deferred studies have been missed. Now, in cases where sponsors fail to seek or obtain an extension or fail request approval for a required pediatric formulation, FDA can send a non-compliance letter and publish it on the web [<a href="http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm343203.htm" target="_blank">Non-compliance Letters</a>]. Last week, FDA published the first of the non-compliance letters and sponsors’ responses. (FDA.gov)<br />
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<strong>Medical device manufacturers are claiming that FDA does not have the legal authority to release masked and de-identified clinical trial data to researchers.</strong> This follows a June, 2013 proposal by the agency’s Regulatory Science Initiative to improve the product development process. [<a href="https://www.federalregister.gov/articles/2013/06/04/2013-13083/availability-of-masked-and-de-identified-non-summary-safety-and-efficacy-data-request-for-comments" target="_blank">Proposal</a>] (The Gray Sheet via Becker)<br />
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<strong>SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS</strong><br />
<strong><a href="http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm" target="_blank">Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015</a></strong><br />
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<strong>Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. September 9-10, 2013.</strong> Discuss ethical issues in pediatric product development, including medical counter measures, focusing on the concepts of minimal risk, disorder or condition, and exposure of pediatric subjects to risks under 21 CFR 50.54. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-08/pdf/2013-19138.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Public Meeting: FDA Patient Network Annual Meeting - Demystifying FDA: An Exploration of Drug Development. September 10, 2013.</strong> This meeting will serve as a forum for FDA’s patient stakeholders and the general public, including health professionals, academia, and industry to learn about regulatory issues related to drug development, analyze where in the process patient input may be most practical and most valuable, and explore practicable approaches to incorporating meaningful patient input that will represent broad patient perspectives in medical product development and regulatory decision-making. <br />
<a href="http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwNzI0LjIxNDQyNTUxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDcyNC4yMTQ0MjU1MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODgxNzk0JmVtYWlsaWQ9ZGVib3JhaC5taWxsZXJAZmRhLmhocy5nb3YmdXNlcmlkPWRlYm9yYWgubWlsbGVyQGZkYS5oaHMuZ292JmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&140&&&http://www.patientnetwork.fda.gov/patient-network-annual-meeting-september-10-2013?source=govdelivery" target="_blank">More information</a><br />
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<strong>NCTR global summit on regulatory science focusing on nanotechnology.</strong> September 11-12, held in Little Rock, AR.)<br />
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<strong>Circulatory System Devices Panel of the Medical Devices Advisory Committee. September 11-12, 2013.</strong> Discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC) devices, one of the remaining preamendments class III devices regulated under the 510(k) pathway. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-13/pdf/2013-19521.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Public Workshop. The Patient Preference Initiative: Incorporating Patient Preference Information Into the Medical Device Regulatory Processes. September 18-19, 2013.</strong> Engage and solicit information from stakeholders on (1) approaches for capturing, collecting, and validating patient preference information; and (2) the incorporation of patient preference information into regulatory review process. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-29/pdf/2013-18080.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Pediatric Advisory Committee.</strong> September 19-20, 2013. Discuss an array of pharmaceutical and medical device pediatric-focused safety reviews as mandated by the Best Pharmaceuticals for Children Act. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-13/pdf/2013-19522.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Public Meeting. Narcolepsy Public Meeting on Patient Focused Drug Development. September 24, 2013.</strong> Obtain patients’ perspectives on the impact of narcolepsy on daily life as well as the available therapies for narcolepsy. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-19/pdf/2013-17327.pdf" target="_blank">FR Notice</a>] This is the 4th in the series of public meetings through which FDA plans to gather input to help assess benefit-risk paradigms that specific patient groups are willing to accept in return for treatment.<br />
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<strong>Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. September 25, 2013.</strong> Discuss optimal strategies for the evaluation, interpretation, and communication of drug-drug interaction (DDI) information through the drug label and labeling materials. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-18/pdf/2013-17212.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Public Workshop. The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop. October 4, 2013.</strong> Discuss information about the FDA and European Medicines Agency (EMA) Orphan Drug Designation programs, the FDA Humanitarian Use Device (HUD) Designation program, and the FDA Orphan Products Grant program to participants representing pharmaceutical, biotechnology, and device companies, as well as academics. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-21/pdf/2013-20371.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products. Public Workshop. October 7, 2013.</strong> Bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products. [<a href="https://s3.amazonaws.com/public-inspection.federalregister.gov/2013-17528.pdf" target="_blank">Federal Register</a>] Location will be White Oak Campus in Silver Springs, MD; the workshop will also be webcast due to limited availability of seating at the live facility.<br />
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<strong>Anti-Infective Drugs Advisory Committee. October 17, 2013.</strong> Discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-07/pdf/2013-19036.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Public Workshop. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics. October 21-22, 2013.</strong> Consider issues related to endpoints that can support drug development for the treatment of pediatric & adult inflammatory bowel disease. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-08-07/pdf/2013-19036.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Cellular, Tissue and Gene Therapies Advisory Committee. October 22-23, 2013.</strong> On October 22, discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. On October 23, hear updates on the guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products. [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-07-23/pdf/2013-17600.pdf" target="_blank">FR Notice</a>]<br />
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<strong>Third Annual Food and Drug Administration Health Professional Organizations Conference. October 24, 2013.</strong> Agenda includes FDA updates, an overview of FDA’s Network of Experts (public/private partnerships), and an FDA Town Hall. [FR Notice]<br />
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<strong>OPDP Enforcement Actions Webinar – October 28, 2013 at 10:30 AM</strong><br />
The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) invites you to participate in the next Enforcement Webinar on October 28, 2013, from 10:30 AM to 11:00 AM (ET). Viewers can begin submitting questions 30 minutes prior to the webinar start time. During the webinar, OPDP will give stakeholders a chance to directly communicate with the Agency about clarifications or questions concerning recent Warning Letters and Untitled Letters issued by OPDP. This particular webinar will cover Warning Letters and Untitled Letters issued from July 2013 through September 2013.<br />
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These focused webinars support OPDP's mission to protect the public health by assuring that prescription drug information is truthful, balanced, and accurately communicated.<br />
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To join the meeting: <a href="https://collaboration.fda.gov/opdp1028?source=govdelivery" target="_blank">https://collaboration.fda.gov/opdp1028</a><br />
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<strong>SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS</strong><br />
<strong>September 4, 2013, the Department of Health and Human Services’ (HHS) Office of Disease Prevention and Health Promotion (ODPHP) solicited public comments on the draft National Action Plan for Adverse Drug Event Prevention</strong>. The draft Action Plan focuses on federal engagement in the surveillance, prevention, incentives, oversight, and research of entities manufacturing or distributing products associated with high levels of harm and adverse events. [<a href="http://www.hhs.gov/ash/initiatives/ade/ade-action-plan.pdf" target="_blank">Action Plan</a>] [<a href="https://www.federalregister.gov/articles/2013/09/04/2013-21434/solicitation-of-written-comments-on-draft-national-action-plan-for-adverse-drug-event-prevention" target="_blank">FR Notice</a>] (FDA.gov)<br />
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<strong>September 4, 2013, the Office of the National Coordinator’s (ONC) Health Information Technology (HIT) Committee released a set of recommendations for mobile health technology regulations.</strong> FDASIA 2012 calls for the HHS Secretary to “post a report—within 18 months (or by January 2014)—that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication”. The committee called on FDA to work within its current regulatory frameworks to allow for the innovation of mobile health technologies, rather than undertake a complete revamp of the current mobile health technology regulations. [<a href="http://www.healthit.gov/facas/calendar/2013/09/04/hit-policy-committee" target="_blank">Meeting Materials</a>] [<a href="http://www.healthit.gov/facas/sites/faca/files/FDASIARecommendationsDraft030913_v2.pdf" target="_blank">Recommendations Draft</a>] (HealthIT.gov)<br />
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<strong>The International Conference on Harmonization (ICH) has issued a statement and published a manual entitled, “ICH Procedures,”</strong> which is intended to create greater transparency on the activities, processes, and procedures conducted by the regulatory entity. The manual summarizes ICH’s “5-Step” regulatory process, and also includes a glossary of terms, definitions and explanations of ICH activities, member roles and responsibilities, and its document templates. [<a href="http://www.ich.org/fileadmin/Public_Web_Site/News_room/B-Press_Releases/ICH_GCG_Press_Releases/Press_Release_Brussels_June_2013.pdf" target="_blank">ICH Statement</a>] [<a href="http://www.ich.org/fileadmin/Public_Web_Site/ABOUT_ICH/Process_of_Harmonisation/ICH_Procedures_V1.0.pdf" target="_blank">ICH Procedures</a>] (Regulatory Focus)<br />
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<strong>The United Kingdom’s National Institute for Health and Care Excellence and India’s Department of Health Research, Ministry of Health and Family Welfare signed a Memorandum of Understanding effective June 14, 2013.</strong> The memorandum confirmed the nations’ goal to strategically and technically collaborate in the development and use of evidence to inform clinical policy and practice in the context of universal healthcare coverage. (BioSpectrum via Becker)<br />
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<strong>August 27, 2013, Germany’s Federal Ministry of Education and Research (BMBF) announced that it will provide up to EUR 27 million through 2018 to fund national and European research for rare disease diagnostics, therapeutic procedures, as well as disease mechanisms and genetic causes.</strong> The effort for this funding was led by Germany’s National Action League for People with Rare Diseases (NAMSE), and the group will now be responsible for implementation of these measures. (BioCentury)<br />
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Last week, the European Public Health Alliance (EPHA), a collaboration of nonprofits and non-government organizations, released a position paper entitled, <strong>“EPHA Position on Proposals for Regulations on Medical Devices & IVD.”</strong> The network maintains in the paper that, following member discussion and European Union (EU) developments, it supports more stringent and aligned procedures, more transparency in the authorization process, and stricter controls and requirements for manufacturers. [<a href="http://www.epha.org/IMG/pdf/EPHA_Position_Medical_Devices_updated_Aug2013_final.pdf" target="_blank">Position Paper</a>] (FierceMedicalDevices via Becker)<br />
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<strong><a href="http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/09/WC500148672.pdf" target="_blank"><br /></a></strong><br />
<strong><a href="http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/09/WC500148672.pdf" target="_blank">Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use</a></strong><br />
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This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar medicines, it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. (EMA) Released September 5, 2013. Document at link above.<br />
<strong><br />Russia Developing New Guidance for IVDs</strong><br />
Russia’s Federal Service on Healthcare Surveillance (Roszdravnadzor) has launched a <a href="http://www.roszdravnadzor.ru/main/oficial/25887" target="_blank">public consultation</a> to develop new guidelines for the evaluation of the quality, effectiveness and safety of in-vitro diagnostics products. According to the agency, the guidance will be prepared under the direction of the Ministry of Health’s Head Specialist for Clinical Laboratory Diagnostics, Anatolia Kochetova, with the assistance of expert organizations and leading experts in the field of in-vitro diagnostics. Representatives of the business community, academia, and professional associations have also offered to take part in the guidelines’ development. (RegLink News)<br />
<strong><br />China-ASEAN Drug Safety Summit Opened</strong><br />
At the <a href="http://www.sfda.gov.cn/WS01/CL0050/90963.html" target="_blank">second session</a> of the China-ASEAN Drug Safety Summit, which opened on September 3 in Nanning, Deputy Commissioner of the China FDA (CFDA) Yin Li noted that the trade volume in the China-ASEAN Free Trade Area increased by 13% to $ 5.114 billion in 2012 from $4.5 billion in 2011. Moreover, Li said that China’s pharmaceutical industry had undergone rapid growth rate of more than 20% annually. The session was co-sponsored by the CFDA and the Guangxi Zhuang Autonomous Region People's Government, with attendance by the Lao People's Democratic Republic Deputy Minister of Health, the Myanmar Deputy Minister of Health, the Socialist Republic of Vietnam Deputy Health Minister and other ASEAN countries as well as the Hong Kong and Macao health and drug regulatory agency representatives. (RegLink News)<br />
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<strong>CFDA Expands Bilateral Agreements</strong><br />
China’s FDA recently expanded bilateral cooperation agreements with two European countries and the World Health Organization (WHO) within a one-week time frame. On August 22, Commissioner Zhang Yong <a href="http://www.sfda.gov.cn/WS01/CL0048/83515.html" target="_blank">met</a> with WHO Director-General Margaret Chan on the ongoing bilateral cooperation on food safety and drug regulatory issues. On August 20, Commissioner Yong <a href="http://www.sfda.gov.cn/WS01/CL0048/83463.html" target="_blank">me</a>t with the Czech Minister of Health and reached agreement on further cooperation and exchanges on drug and medical device regulatory matters. On August 16, Deputy Commissioner Yin Li <a href="http://www.sfda.gov.cn/WS01/CL0048/83448.html" target="_blank">met</a> with Swiss Federal Councilor and Minister of the Interior, Mr. Seth Alan Bell, on a bilateral regulatory cooperation memorandum. (RegLink News)<br />
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<strong>Bill creating Indian Central Drugs Authority introduced</strong><br />
Legislation has been introduced in India that would establish a new Central Drugs Authority (CDA) with overarching power to regulated drugs, devices and cosmetics. The Drugs and Cosmetics (Amendment) Bill, 2013, introduced today in the Rajya Sabha (Upper House of Indian Parliament) by Health and Family Welfare Minister Ghulam Nabi Azad would replace the Drugs and Cosmetics Act, 1940.<br />
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The CDA would be composed of 19 members, headed by the Secretary of Health and Family Welfare. It would establish regulations and norms for effective functioning of central and state drug licensing authorities and periodically assess their functioning. The new agency would also have the authority to review, suspend or cancel any permission or license for drugs and cosmetics manufacturing.<br />
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The bill establishes centralized licensing for 17 categories of critical drugs, and includes separate chapters with regulatory frameworks governing medical devices, product exports and clinical trials, including provision for compensation for deaths or injury of a trial subjects. Penalties for violations are also set forth in the bill. (RegLink News)<br />
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<strong>August 30, 2013, India’s Central Drugs Standard Control Organization (CDSCO) issued a notice explaining the requirement that payment and legal agreements between sponsors and trial investigators be disclosed in clinical trial applications.</strong> India’s Good Clinical Practices (GCP) regulations now require contracts between trial investigators and sponsors be completed prior to the start of the study, with financial support information and the nature of their relationship clearly defined. [<a href="http://www.cdsco.nic.in/Furnising%20of%20information%20in%20respect%20of%20financial%20support%202013.pdf" target="_blank">CDSCO Notice</a>]<br />
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<strong>SECTION 5 LEGAL, POLICY, AND COMPLIANCE NEWS</strong><br />
<strong><a href="http://www.pharmalive.com/that-flushing-sound-pharma-loses-lawsuit-over-take-back-law?cid=nl.phrm01" target="_blank">Pharma Loses Lawsuit Over Take-Back Law</a></strong><br />
<a href="http://www.pharmalive.com/that-flushing-sound-pharma-loses-lawsuit-over-take-back-law?cid=nl.phrm01" target="_blank"></a><br />
In a rebuke to the pharmaceutical industry, a federal judge has dismissed a lawsuit that charged a California county acted inappropriately last year by passing an ordinance that requires drugmakers and biotechs to cover the cost of a prescription drug ‘take back,’ or disposal program. <br />
County officials pointed out that drugmakers make money from the sale of medicines and, therefore, should also have an obligation to help with appropriate disposal. But in its lawsuit, the PhRMA trade group maintained that safe disposal of unwanted medicines is a shared responsibility and the ordinance unfairly requires drugmakers to develop, manage and fund disposal operations. Failure to comply carries up to a $1,000 per day fine. Full article at link above. (Pharmalot)<br />
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<strong><a href="http://www.raps.org/focus-online/news/news-article-view/article/4032/as-fda-considers-first-wave-of-biosimilar-drugs-are-states-limiting-their-event.aspx" target="_blank">As FDA Considers First Wave of Biosimilar Drugs, Are States Limiting Their Eventual Impact?</a></strong><br />
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This is an interesting article about the California bill to prevent substitution of a biosimilar for a reference biologic licensed drug unless FDA has specifically found the two products to be interchangeable. Both FDA and GPhA have criticized the bill, indicating that it would create unnecessary barriers between patients and new, lower-cost versions of biologic therapies. <br />
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The bill (SB 598) has been approved in both the Assembly and the Senate and was sent to the Governor’s desk on September 4 for signature. Full article at link above. (Regulatory Focus)<br />
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<strong><a href="http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/09/biosimilars-state-legislation-scorecard.html" target="_blank">Biosimilars State Legislation Scorecard</a></strong><br />
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With the news last week that the Assembly in the bellwether state of California passed a bill – S.B. 598 – by a 58-4 vote concerning the substitution of biosimilar and interchangeable biosimilar products for their brand-name reference product counterparts, and with bills currently passed, failed or pending in other states (and the likelihood that legislation will continue to be pushed in several states for some time to come), we thought it was high time to put together a new scorecard – the Biosimilars State Legislation Scorecard – to keep tabs on such legislation.<br />
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See full article at link above. (FDA Law Blog)<br />
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<strong>SECTION 6 SOURCES REVIEWED FOR THIS NEWSLETTER</strong><br />
<strong>A partial listing of sources reviewed for this newsletter:</strong> AdvaMed Smartbrief; AHRQ Newsletter; Alzheimers Association; Alzheimers Research Forum Newsletter; BioCentury; Biopharma Reporter; BIOtechNow; CDISC Monthly Newsletter; CER Daily Newsfeed (NPC); Daily Dose (Becker); DIA Daily; Drug Daily Bulletin; Eye on FDA; Federal Register Table of Contents; Fierce Medical Devices; Fierce Pharma; Fierce Vaccines; FDLI Smartbrief; Health Industry Washington Watch; Institute of Medicine Report; Medical Device Daily; Medical Device & Diagnostic Industry; NPC Bulletin; Pharmabiz; Pharmalot; PharmaTimes; PhRMA website; PM Live; Policy and Medicine (newsletter); Regulatory Focus; RegLink News; US FDA Daily Digest Bulletin.<br />
- See more at: <a href="http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z#sthash.e8E3QyYY.dpuf">http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z#sthash.e8E3QyYY.dpuf</a><br />
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<span style="color: #555555; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://mailview.bulletinhealthcare.com/mailview.aspx?m=2013082701dia&r=4961050-a4c3&l=017-87a&t=c"><span style="color: #0e4d96;">The Electronic Trial Master File: So Much More than Just
a Secure Document Repository</span></a><b><br />
</b>September 17 | 1:00-2:30 PM ET<br />
Brought to you by DIA in cooperation with NextDocs<br />
<br />
Implementing an electronic Trial Master File (eTMF) is becoming a standard
business model for the clinical industry. The benefits of moving to an eTMF
have been well documented, e.g. increased TMF quality, efficiency, and access to
all stakeholders. However, there are additional benefits when considering the
move to an eTMF, such asthe benefits gained from leveraging the data within the
eTMF.<br />
<br />
This FREE webinar will demonstrate how to leverage data to maximize the
potential of an eTMF. Presenters will include Sharon Ames, Enterprise Program
Director at NextDocs Corporation, and Gabor Fari, Director of Life Sciences
Solutions at Microsoft Corporation.<o:p></o:p></span></div>
<br />
<div style="line-height: 11.25pt;">
<span style="color: #555555; font-family: "Arial","sans-serif"; font-size: 9pt;">Featured topics:<o:p></o:p></span></div>
<br />
<ul type="disc">
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Using eTMF Data to Define and Measure Key Performance
Indicators and Operational Metrics<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Search vs. Findability – Obtaining Quick and Thorough
Query Results<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Using Interoperability and Standards for Streamlining
the Clinical Trial Process<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l0 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Ensuring the Availability of Data through Recommended
and Mandatory Metadata<o:p></o:p></span></li>
</ul>
<br />
<div style="line-height: 11.25pt;">
<span style="color: #555555; font-family: "Arial","sans-serif"; font-size: 9pt;">Who Should Attend? Professionals involved in:<o:p></o:p></span></div>
<br />
<ul type="disc">
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Coordinating and Managing Clinical Trial Operations for
Drug Development in Sponsor or CRO Organizations<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Optimizing Clinical Trial Business Processes<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Administering and Reconciling TMF Records<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Overseeing Regulatory Compliance and Audit Readiness
for Clinical Trials<o:p></o:p></span></li>
<li class="MsoNormal" style="color: #555555; line-height: 11.25pt; margin: 0in 0in 0pt; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list .5in;"><span style="font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">Maintaining IT Infrastructure for Clinical Trials<o:p></o:p></span></li>
</ul>
<br />
<div style="line-height: 11.25pt;">
<span style="color: #555555; font-family: "Arial","sans-serif"; font-size: 9pt;"><a href="http://mailview.bulletinhealthcare.com/mailview.aspx?m=2013082701dia&r=4961050-a4c3&l=018-d79&t=c"><span style="color: #0e4d96;">Overview</span></a> <b>| </b><a href="http://mailview.bulletinhealthcare.com/mailview.aspx?m=2013082701dia&r=4961050-a4c3&l=019-1fa&t=c"><span style="color: #0e4d96;">Register Online for FREE!</span></a><o:p></o:p></span></div>
</div>
Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-38348928658642074912013-08-23T05:44:00.000-07:002013-09-25T10:00:42.186-07:00第10回 DIA日本年会 ~ 日本発の創薬革命 ~ 革新的創薬・育薬に向けた アカデミア・行政・企業の果たすべき役割<div style="text-align: left;">
<a href="http://bit.ly/DIASmartBrief"><span style="color: blue; font-family: Verdana, sans-serif; font-size: x-small;">Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.</span></a> </div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br /></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br /></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><div align="LEFT" style="text-align: left;">
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新薬の開発には膨大な時間と開発費用が必要であるにも関わらず、新規化合物</div>
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が臨床開発を経て、医薬品として承認される成功確率は数万分の1とも言われ、</div>
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その困難さは今後も増大するものと予想されています。海外に目を向けますと、</div>
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米国NIHに代表されるように、国を挙げて化合物スクリーニングや化合物ライブラ</div>
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リーの構築を進めています。</div>
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我が国においても、早期開発の重要性が指摘されており、特にアカデミアやベン</div>
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チャー企業により発見された有望な新規化合物の医薬品開発は喫緊の課題で</div>
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す。平成</div>
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<span style="font-family: MyriadPro-Regular; font-size: xx-small;"><span style="font-family: MyriadPro-Regular; font-size: xx-small;">23</span></span><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;">年には、PMDAにおいて薬事戦略相談制度が導入されアカデミア等に</span></span></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;">
</span></span></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br /></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br /></div>
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><div align="LEFT" style="text-align: left;">
対する支援体制がスタートしました。また、早期・探索的臨床試験拠点や臨床研</div>
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究中核病院の整備も進んでおり、革新的医薬品/医療機器の開発を推進するこ</div>
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とが期待されます。しかしながら、アカデミア、行政、企業、さらには患者さんの視</div>
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点も加わった連携の中で日本発医薬品/医療機器の開発がなされるには未だ</div>
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多くの課題を抱えています。</div>
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そこで、本年会ではアカデミア、行政、企業、患者さんが一体となって革新的医薬</div>
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品の創薬・育薬を進めていくには何をすべきかを中心に議論を行います。AROな</div>
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ど医療機関に関係するセッションや、コンパニオン診断薬の問題と解決策など、</div>
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医療現場においても有用なセッションを用意しています。医薬品開発の国際化が</div>
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加速する中で、日本は何をすべきかをアカデミア、臨床、プロジェクトマネジメン</div>
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ト、薬事等の視点から広範囲な議論を行います。薬事法やGCPの改正をはじめと</div>
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する幅広い最新情報を提供するために、本年も</div>
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<span style="font-family: MyriadPro-Regular; font-size: xx-small;"><span style="font-family: MyriadPro-Regular; font-size: xx-small;">6</span></span><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;">Trackによる進行とし、多数のセ</span></span></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;">
</span></span></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br /></div>
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<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br /></div>
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"></span></span><br />
<span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: xx-small;"><div align="LEFT" style="text-align: left;">
ッションを開催します。</div>
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また、今年の年会の大きな特色として、ICH大阪会議の直前に開催されることか</div>
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ら、多くのICH関係者が演者もしくはパネリストとして参加を予定しています。医薬</div>
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品開発に関わる方々にとって、有益な情報交換の場となるものと思いますので、</div>
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<br />
一人でも多くの皆様のご参加をお待ちしています。</div>
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<span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: small;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: small;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: small;"></span></span></span><br />
<span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: small;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: small;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: small;"><div align="LEFT">
</div>
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****</div>
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日本語・英語間の同時通訳あり</div>
</span></span></span><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: x-small;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: x-small;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic; font-size: x-small;"><div align="LEFT">
(一部セッションを除く)</div>
</span></span></span><span lang="JA" style="color: #00549f; font-family: MS-PGothic;"><span lang="JA" style="color: #00549f; font-family: MS-PGothic;"><div align="LEFT">
展示申込受付中</div>
</span></span><span lang="JA" style="font-family: MS-PGothic; font-size: x-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: x-small;"><div align="LEFT">
詳細については、下記までお問い合わせください。</div>
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一般社団法人ディー・アイ・エー・ジャパン</div>
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〒</div>
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</span><br />
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<span style="font-family: MyriadPro-Regular; font-size: x-small;"><span style="font-family: MyriadPro-Regular; font-size: x-small;">106-0041 </span></span><span lang="JA" style="font-family: MS-PGothic; font-size: x-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: x-small;">東京都港区麻布台</span></span><span style="font-family: MyriadPro-Regular; font-size: x-small;"><span style="font-family: MyriadPro-Regular; font-size: x-small;">1-11-10 </span></span><span lang="JA" style="font-family: MS-PGothic; font-size: x-small;"><span lang="JA" style="font-family: MS-PGothic; font-size: x-small;">日総第22ビル</span></span><span style="font-family: MyriadPro-Regular; font-size: x-small;"><span style="font-family: MyriadPro-Regular; font-size: x-small;">7F</span></span></div>
<span style="font-family: MyriadPro-Regular; font-size: x-small;"><span style="font-family: MyriadPro-Regular; font-size: x-small;">
</span></span><br />
<span style="font-family: MyriadPro-Regular; font-size: x-small;"><span style="font-family: MyriadPro-Regular; font-size: x-small;"><div align="LEFT">
Tel: 03-5575-2130</div>
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Fax: 03-3583-1200</div>
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email: </div>
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</span><br />
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<span style="font-family: MyriadPro-Regular; font-size: xx-small;"><span style="font-family: MyriadPro-Regular; font-size: xx-small;">diajapan@diajapan.org</span></span></div>
<span style="font-family: MyriadPro-Regular; font-size: xx-small;"><span style="font-family: MyriadPro-Regular; font-size: xx-small;">
</span></span><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"></span></span></span><br />
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第</div>
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<span style="color: white; font-family: MyriadPro-Regular; font-size: x-large;"><span style="color: white; font-family: MyriadPro-Regular; font-size: x-large;"><span style="color: white; font-family: MyriadPro-Regular; font-size: x-large;">10</span></span></span><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;">回 </span></span></span><span style="color: white; font-family: MyriadPro-Regular; font-size: x-large;"><span style="color: white; font-family: MyriadPro-Regular; font-size: x-large;"><span style="color: white; font-family: MyriadPro-Regular; font-size: x-large;">DIA</span></span></span><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;">日本年会</span></span></span></div>
<span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;">
</span></span></span><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"></span></span></span><br />
<span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><span lang="JA" style="color: white; font-family: MS-PGothic; font-size: x-large;"><div align="LEFT">
日本発の創薬革命</div>
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~ 革新的創薬・育薬に向けた</div>
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アカデミア・行政・企業の果たすべき役割 ~</div>
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2013</div>
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<span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">年</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">11</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">月</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">6</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">日</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">(</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">水</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">)</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">~</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">8</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">日</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">(</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">金</span></span><span style="color: white; font-family: MyriadPro-Regular;"><span style="color: white; font-family: MyriadPro-Regular;">)</span></span></div>
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</span></span><span lang="JA" style="color: white; font-family: MS-PGothic;"><span lang="JA" style="color: white; font-family: MS-PGothic;">TFT東京ファッションタウンビル(有明)</span></span></div>
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-81424094265529981182013-05-02T12:42:00.000-07:002013-05-02T12:42:22.440-07:00Latest Edition of DIA's Content Currents is available (April 26, 2013)<div style="text-align: left;">
<a href="http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z"><img alt="DIA" src="http://www.diahome.org/~/~/media/News-and-Publications/DIA-Cover-133x170.ashx" style="float: left; margin-bottom: 10px; margin-right: 10px;" /></a><br />
<br />
DIA's<em> Content Currents</em> provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.<br />
<em></em><br />
<em></em><br />
<em>EDITION PUBLISHED: APRIL 26, 2013</em><br />
<em></em><br />
<strong></strong><br />
<strong>SECTION 1: FDA GUIDANCES</strong><br />
April 23, FDA announced the availability of a draft guidance document for industry entitled, “<strong>Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.</strong>” This draft guidance is intended to aid prescription drug and biologic manufacturers in minimizing medication errors by focusing on safety aspects of the container label and carton labeling design. The 60 day comment period will close June 22, 2013. [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf" target="_blank">Draft Guidance</a>] (<a href="http://www.fda.gov/" target="_blank">FDA.gov</a>)<br /><br />April 23, FDA announced the availability of a draft guidance document entitled, “<strong>Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.’</strong>” This draft guidance is intended to aid sponsors in determining the potential toxicity of medical devices contacting the skin, clarify the Office of Device Evaluation General Program Memorandum #G95-1, and replace the memorandum when made final. [<a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM348890.pdf" target="_blank">Draft Guidance</a>] [<a href="http://www.gpo.gov/fdsys/pkg/FR-2013-04-23/pdf/2013-09479.pdf" target="_blank">FR Notice</a>]<br /><br />April 25, FDA announced the availability of a final guidance document entitled, “<strong>Assay Migration Studies for In Vitro Diagnostic Devices.</strong>” This guidance document is intended to provide a least burdensome approach to earn FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when an already approved assay is transitioning to a new system. [<a href="http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092752.pdf" target="_blank">Guidance</a>] <br /><br />April 25, FDA also announced the availability of a final guidance document for industry entitled, “<strong>Regulatory Classification of Pharmaceutical Co-Crystals.</strong>” This guidance document is intended to aid sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) by informing them of the type of data that should be submitted to support the application. [<a href="http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM281764.pdf" target="_blank">Guidance</a>] <em>Note: the link appears to be temporarily unavailable as of 4/25/13.</em> (<a href="http://www.fda.gov/" target="_blank">FDA.gov</a>)<br />
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<em></em><br />
<em>For complete update, please visit </em><a href="http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z"><em>http://www.diahome.org/~/link.aspx?_id=CA3173B02837442185CDC0BFA47C58F0&_z=z</em></a><br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-49086154208601283472013-05-01T09:30:00.000-07:002013-05-01T09:30:03.555-07:00How does the Japanese regulatory system impact on local and global drug development strategies? <div style="text-align: left;">
<u><span style="color: #0066cc; font-family: Verdana, sans-serif;">Japan's Regulatory Environment: Overview of the Organization, Processes, Systems and Changes Affecting Pharmaceutical Development: </span></u><br />
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Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-70552289857360490972013-04-30T12:28:00.002-07:002013-04-30T12:52:54.033-07:00Calling all Life Science Students<div align="left">
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<strong><span style="color: #75263d; font-family: Verdana, sans-serif; font-size: x-small;">4 Days. 22 Tracks. 250+ Educational Offerings. 450+ Exhibitors. 7,000+ Attendees.</span></strong></div>
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<strong><span style="color: #75263d; font-family: Verdana, sans-serif; font-size: x-small;">Student Forum</span></strong><span style="color: #5f6168;"><br /><span style="font-family: Verdana, sans-serif; font-size: x-small;">
</span><a href="http://echo4.bluehornet.com/ct/20714144:22627821704:m:1:1378935879:85D645E259FF25D2430C7D31F8599CF5:r"><span style="color: #003591; font-family: Verdana, sans-serif; font-size: x-small;">“Getting
a Job and Developing a Career”</span></a><br /><span style="font-family: Verdana, sans-serif; font-size: x-small;">
June 25 | 10:15-11:45AM ET<br />
This year’s forum will cover getting a job with presentations on soft
skills, interviewing and using internships and fellowships to launch your
career. An additional topic - finding a mentor - will introduce the theme
of going from finding a job to developing a career. A good mentor can
guide you with priceless tacit knowledge that otherwise could take years
to find.<br />
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</span></span><strong><span style="color: #75263d; font-family: Verdana, sans-serif; font-size: x-small;">Speakers: </span></strong><span style="color: #5f6168;"><br /><span style="font-family: Verdana, sans-serif;"><span style="font-size: x-small;">
<strong>Soft Skills and
Interviewing</strong><br />
<strong>Kelleen Flaherty,
MS,</strong> Assistant Professor, University of the Sciences in
Philadelphia<br />
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<strong>Using Fellowships
and Internships to Start Your Career</strong><br />
<strong>Justin Balint,
PharmD,</strong> Post-Doctoral Fellow, Oncology Advocacy and
Policy, Rutgers<br />
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<strong>Finding a Mentor
to Guide your Career</strong><br />
<strong>Amy N. Grant, MS,</strong>
Director, Global Regulatory Strategy & Science, ViroPharma Inc.<o:p></o:p></span></span></span></div>
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<strong><span style="color: #75263d; font-family: Verdana, sans-serif; font-size: x-small;">Career Center</span></strong><span style="color: #5f6168;"><br /><span style="font-family: Verdana, sans-serif; font-size: x-small;">
The </span><a href="http://echo4.bluehornet.com/ct/20714145:22627821704:m:1:1378935879:85D645E259FF25D2430C7D31F8599CF5:r"><span style="color: #003591; font-family: Verdana, sans-serif; font-size: x-small;">DIA
Career Center</span></a><span style="font-family: Verdana, sans-serif;"><span style="font-size: x-small;"> is your go-to resource for careers in the life sciences
industry. Use the Career Center to find your ideal job or internship
today!<o:p></o:p></span></span></span></div>
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<strong><span style="color: #75263d; font-family: Verdana, sans-serif; font-size: x-small;">Continuing Education
Credits</span></strong><span style="color: #5f6168;"><br /><span style="font-family: Verdana, sans-serif; font-size: x-small;">
Earn </span><a href="http://echo4.bluehornet.com/ct/20714146:22627821704:m:1:1378935879:85D645E259FF25D2430C7D31F8599CF5:r"><span style="color: #003591; font-family: Verdana, sans-serif; font-size: x-small;">CE
credits</span></a><span style="font-family: Verdana, sans-serif;"><span style="font-size: x-small;"> for attending sessions, forums, workshops, symposia, and more<o:p></o:p></span></span></span></div>
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<strong><span style="color: #75263d; font-family: Verdana, sans-serif; font-size: x-small;">Network! Network!
Network! </span></strong><span style="color: #5f6168;"><br /><span style="font-family: Verdana, sans-serif;"><span style="font-size: x-small;">
Receptions, Networking Lunches, Student & Professional Posters, Speed
Networking Session<o:p></o:p></span></span></span></div>
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This Year's Student and Professional Posters<o:p></o:p></span></span></span></div>
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<span style="color: #75263d; font-family: Verdana, sans-serif; font-size: xx-small; mso-fareast-font-family: "Times New Roman";"><strong>Student Group
Discounts Available!</strong></span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><br /><span style="font-family: Verdana, sans-serif; font-size: x-small;">
Register 10 from
your university and receive the 11th </span></span><span style="font-family: Verdana, sans-serif;"><span style="font-size: x-small;"><span style="color: #75263d; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">FREE</span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";">! </span></span></span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><br /><span style="font-family: Verdana, sans-serif; font-size: x-small;">
Contact Donna
Mayer at </span><a href="mailto:donna.mayer@diahome.org"><span style="color: #003591; font-family: Verdana, sans-serif; font-size: x-small;">donna.mayer@diahome.org</span></a><span style="font-family: Verdana, sans-serif; font-size: x-small;">
</span></span><br />
<span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><span style="font-family: Verdana, sans-serif; font-size: x-small;">for eligibility and registration details.</span></span><span style="color: #5f6168; font-family: "Arial","sans-serif"; font-size: 9pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
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<a href="http://www2.smartbrief.com/signupSystem/subscribe.action?pageSequence=1&briefName=dia&campaign=careercenter"><span style="color: blue; font-family: Verdana, sans-serif; font-size: x-small;">Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.</span></a><span style="font-family: Verdana, sans-serif; font-size: x-small;">
</span>Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0tag:blogger.com,1999:blog-459492395198000471.post-4715260817671930402013-04-30T09:30:00.000-07:002013-04-30T09:30:02.560-07:00What's the best way to identify and correct dysfunctional group dynamics?<div style="text-align: left;">
<a href="http://bit.ly/16ks2bG"><span style="font-family: Verdana, sans-serif;">Leadership: How to Organize and Lead People in Group Work</span></a><span style="font-family: Verdana, sans-serif;"> - June 23 from 8:30AM – 12:00PM in Boston</span><br />
<span style="font-family: Verdana, sans-serif;"></span><br />
<span style="font-family: Verdana, sans-serif;">This tutorial is designed for individuals who must manage group activities on a permanent or project basis, for those who must work on teams but are not in charge of teams and are interested in learning how to exert influence on group behavior, and for individuals to whom project managers report. The role of a leader in organizing and leading a group is often misunderstood and, as a consequence, the group may not perform up to expectations, or it may spend a considerable amount of time dealing with dysfunctional group dynamics instead of the work to be accomplished. This tutorial addresses those issues by exploring the types of work groups, how they can be more effective, and how individuals can correct group dynamics and help the group achieve higher levels of performance.</span><br />
<span style="font-family: Verdana, sans-serif;"></span><br />
<span style="font-family: Verdana, sans-serif;">Instructor:<br />Michael Laddin, MBA,MS<br />CEO<br />LeaderPoint, United States</span><br />
<span style="font-family: Verdana, sans-serif;"></span><br />
<span style="font-family: Verdana, sans-serif;">What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.</span><br />
<span lang="EN" style="font-family: "Calibri","sans-serif"; font-style: normal; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><span style="font-family: Verdana, sans-serif;"></span></span><br />
<span lang="EN" style="font-family: "Calibri","sans-serif"; font-style: normal; mso-ansi-language: EN; mso-ascii-theme-font: minor-latin; mso-bidi-language: AR-SA; mso-fareast-font-family: Calibri; mso-fareast-language: EN-US; mso-fareast-theme-font: minor-latin; mso-hansi-theme-font: minor-latin;"><span style="font-family: Verdana, sans-serif;">Visit </span><a href="http://www.diahome.org/DIA2013"><span style="color: windowtext;"><span style="background-color: cyan; font-family: Verdana, sans-serif;">www.diahome.org/DIA2013</span></span></a><span style="font-family: Verdana, sans-serif;"> for more details on
the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.</span></span><br />
<br />
<a href="http://www2.smartbrief.com/signupSystem/subscribe.action?pageSequence=1&briefName=dia&campaign=careercenter"><span style="color: blue; font-family: Verdana, sans-serif; font-size: x-small;">Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.</span></a> </div>
Anonymoushttp://www.blogger.com/profile/16305992713974404155noreply@blogger.com0