The founder of the European Medicines Agency (EMA), Fernand Sauer, will give the keynote speech at 10th Annual Meeting DIA Japan.

One Month Left to Book Your Seat to Hear Fernand Sauer and Other Prominent Speakers The founder of the European Medicines Agency (EMA), Fernand Sauer, will give the keynote speech at 10th Annual Meeting DIA Japan. 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. 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. 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. Find Out More Download Program Register Session highlights include: Drug Development Through Collaboration with ARO and Future Risk-based Approach to Monitoring Multiregional Drug Development Asia Town Hall Effective Consultation Strategy in Global Development based on Consultation Examples from Japan and Other Regions Globalization of ICH Guidelines Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine The Regulation, Development, and Future of Biosimilars Find Out More Download Program Register

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DIA's Annual Canadian Meeting: New Reality/New Frontiers

DIA's Annual Canadian Meeting: New Reality/New Frontiers DIA Members Save $150. Early-bird expires October 7. 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.  Opening Remarks: Kathryn McDade Assistant Deputy Minister of the Health Products and Food Branch Health Canada Plenary Sessions:     • International Regulatory Cooperation            - Trends and Impacts            - Stakeholder Perspective Break Out Sessions:     • Harmonizing in the Post-Approval Pharmacovigilance:       Challenges and Opportunities     • Social Media     • Update on ICH: What You Need to Know     • Research Networks and Translational Medicine     • Support Programs: The Pursuit of Patient Advocacy     • Update on the Legislative and Regulatory Modernization Initiative     • IT Modernization     • Plain Language Labeling in the Regulatory System: Consumer- and       Patient- Centered Information     • Publicly Accessible Registries: What Clinical Trial Information Needs       to be Disclosed?     • Cool Tools in Medical Devices     • Plus More Tutorial Topics:     • The Emerging PV Landscape in Canada     • Trends in Health Canada Inspections Register 3, Get the 4th FREE! Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time. Table Top Exhibits: Showcase your products and services to key decision makers in Canada. View Application Now.   View Agenda | Overview | Register Now

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What are the ethical considerations in conducting clinical research?

Overview of Drug Development
June 23 from 9:00AM – 5:00PM in Boston

This tutorial will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development.

Instructor:
George H. D'Addamio, PhD
President
PharmConsult Inc., United States

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.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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第10 回 DIA日本年会

 

 

Save the Date: 第10 回 DIA日本年会

11月6月8日

お問い合わせ

 

November 6-8
10th Japan Annual Meeting
TFT, Tokyo

 

 

私のサイトを訪問していただきありがとうございます、素晴らしい一日を過ごす。

DIA Japan
詳細については、DIAジャパンにお問い合わせください。
電話番号：+81-3-5575-2130
ファックス：+81-3-3583-1200
メールアドレス：DIAJapan@diajapan.org

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Are we making progress in streamlining drug development?

  

Wednesday, June 26

 

Collaborating to Streamline Drug Development: Are We Making Progress?
In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites.

 

TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically, and uses adaptive onsite monitoring to further support subject safety and data quality.

Join high-profile global regulators, industry professionals, and academia to discuss current regulatory landscape in Latin America

Plan your Attendance at LARC 2013 Take a look at this overview of the insightful sessions coming to the Latin American Regulatory Conference (LARC) 2013. Not registered yet? Book your seat before April 12 to save with an early-bird discount! Join high-profile global regulators, industry professionals, and academia to discuss the current regulatory landscape and its impact on future research and drug development at the event in Bogota, Colombia from May 15-16. Find Out More Download the Program Register 2012 VIDEO HIGHLIGHTS Watch videos from last year’s Latin American conferences and get a taste of what you can expect from these insightful events in 2013. IT ONLY TAKES A FEW MINUTES... Update your customer profile to ensure that you receive communications tailored to your specific area(s) of interest. Session Highlights Updates on Regional and Global Convergence with perspectives from Chile, Colombia, Canada, the PAHO and WHO Latin American Agencies Profiles by CIRS: Number of Reviewers, Inspectors, Timeliness, Predictability and Quality of a Full Review Case Study: Challenges faced by Regulators in the Adoption of Internationally Recognized Technical Guidance Documents and Standards Risk Based Approach to Inspections Integrity of the Supply Chain: Serialization, Counterfeits and Disposal of Expired Drugs Transparency of Review Process Health Technology Assessment Implementation of e-Submissions “Miracle” Drugs and Pharmaceutical Products Bordering Dietary Supplement Find Out More Download the Program Register

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