Exclusive Offer to DIA Members: Register for Two Webinars and Save $250.

Exclusive Offer to DIA Members: Register for Two Webinars and Save $250. Busy life sciences professionals need affordable, convenient, and immediate access on the latest developments in the ever-changing health care industry. DIA webinars offer just that - access to timely and authoritative information. Take advantage of this special offer. Offer ends October 18. Check Out These Hot Topics: The Current State of Quality Oversight in the Pharmaceutical Industry October 9 | 11:00AM-12:30PM ET 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. Connecting the Right Sites to Promising Trials: The Role of Web-based Feasibility Assessment October 23 | 11:00AM-12:30PM ET 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. FDASIA Year in Review October 24 | 11:00AM-12:30PM ET 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. CDER Town Meeting: Safety Hot Topics October 30 | 2:30-4:00PM ET 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. CardioVascular Safety: The New Paradigm - Proarrhythmic Assessment of New Drugs Without the Thorough QT Study October 31 | 11:00AM-12:30PM ET 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. CardioVascular Safety – What are the Key Issues Regarding Blood Pressure Assessment During Clinical Development November 7 | 11:00AM-12:30PM ET 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. Aligning the Voices of Change in the Health Care System November 12 | 11:00AM-12:30PM ET 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. More Upcoming Webinars: Practical Aspects and Examples of Using Large Datasets for Identifying and Investigating Product Safety and Effectiveness in the US and EU November 18 | 11:00AM-12:30PM ET The Case of the New England Compounding Center: Learning from the Tragedy November 19 | 11:00AM-12:30PM ET Social and Collaborative Tools in Regulatory Intelligence November 21 | 11:00AM-12:30PM ET Electronic Submissions 101 – Essential MS Word and Adobe Acrobat Tools/Skills and Current IT Options December 4 | 11:00AM-12:30PM ET Combination Products and Convergence: An Overview of Clinical Benefits, Regulatory Issues & Manufacturing Challenges December 5 | 11:00AM-12:30PM ET Global Overview - Economic Power in Asian Countries December 11 | 11:00AM-12:30PM ET View the Full List of Webinars for Complete Details *Offer only valid for webinars included in this email and cannot be combined with any existing promotions.

Email Preferences | My DIA | Forward to a Friend |

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

DIA 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。）

DIA 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。） この度、11月6日（水）にDIA Advanced Regulatory Affairs 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6回開催致しましたDIA Regulatory Affairs 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。   場所：                 TFT東京ファッションタウンビル 研修室 905（東館9階） 参加対象   ：　  企業において薬事を担当している方（薬事経験5年以上が望ましい）またはPMDAにおいて審査・調査を担当している方（審査・調査経験3年以上が望ましい） * 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。 募集人数　：　 32名（8名/グループ× 4グループ） 応募期間　：　 10月3日（木）まで *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。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。 お申込方法：こちらの申込書に必要事項をご記入の上、FAX（03-3583-1200）またはメール添付(diajapan@diajapan.org)にてお申し込みください。   プログラム詳細／申込書はこちら なお、本トレーニングは第10回 DIA 日本年会の初日に、同じ会場（TFT東京ファッションタウンビル）にて開催されます。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。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。  第10回DIA日本年会プログラム    オンライン申込

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now

Essentials for Success! – Join DIA China Medical Affairs and Medical Writing Training Now December 9-10, 2013 | Shanghai, China 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. Who Should Attend Medical Affairs Medical/Scientific Writing Clinical Research & Development Medical Communications/Information Professional Development Download the Program   Program Chairperson   Main Instructors   Min IRWIN, MD, PhD Vice President, Medicines Development, GlaxoSmithKline, China   Karen WOOLLEY, PhD CEO, ProScribe Medical Communications, China, Japan & Australia Professor, University of Queensland and University of the Sunshine Coast, Australia Julie MONK, PhD Medical Writer, ProScribe Medical Communications, China, Japan & Australia Upcoming Event DIA China Member Online Management Dear Member DIA China Member Management is now online. You can log in DIA China website at www.diachina.org to view and manage your data for receiving the latest international pharmaceutical information.

Email Preferences    |    My DIA    |    Forward to a Friend    |

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Pharma professionals, looking for CE credit from PMI?

CONTINUING EDUCATION

The DIA 2013 49th Annual Meeting is the premier event for professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related products.

http://www.diahome.org/en-US/Flagship-Meetings/DIA2013/Meeting-Program/Continuing-Education-Credits.aspx

• Title: #25: Leadership: How to Organize and Lead People in Group Work
  Event Type: TUTORIAL
  Credits: IACET, PMI                                   
• Title: #55: Overview of Drug Development
  Event Type: TUTORIAL
  Credits: IACET, PMI                                  
• Title: Shape Your Cost with Hard and Soft Coverage Analysis Trends
  Event Type: WORKSHOP
  Credits: CME, IACET, PMI, RN                                     
• Title: Portfolio Management Symposium
  Event Type: SYMPOSIUM
  Credits: IACET, PMI
• Title: The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                             
• Title: Bridging the Gap Between Strategy and Execution
  Event Type: SYMPOSIUM
  Credits: CME, IACET, PMI, RN                                                              
• Title: Taking the Measure of Metrics
  Event Type: SYMPOSIUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Pharma, Academia and CRO Preferred Partnerships: Why Collaboration Makes a Better Global Trial
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Innovative Computerized System Validation and Auditing
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Domestic and Global Trends in Clinical Trial Budgeting
  Event Type: WORKSHOP
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Change Order Panel Discussion and Brainstorming Session: Can We Be More Efficient?
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Evaluating Sites for Optimum Site Selection and Performance
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: How Strategic Is Strategic Outsourcing, and for Whom?
  Event Type: SESSION
  Credits: IACET, PMI                                                                      
• Title: Is This Trial Worth It? A Panel Discussion for Sites and Project Managers
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Careers Beyond Project and Portfolio Management: A Panel Discussion
  Event Type: FORUM
  Credits: IACET, PMI                                                                      
• Title: Making CRO-Sponsor Partnerships Work: Executive Roundtable
  Event Type: FORUM
  Credits: IACET, PMI                                                                      
• Title: Using Competence Models to Drive High Quality Drug Project Management
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Towards an Effective Virtual R&D Team for Faster Accessing of the East Asian Market
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Innovative Strategies for Evolving Sponsor, CRO and Site Alliances
  Event Type: SESSION
  Credits: IACET, PMI                                                                      
• Title: Pharmaceutical Project Management: What's Really Important and How Can We Do Better?
  Event Type: SESSION
  Credits: IACET, PMI                                                                      
• Title: Partnering and Outsourcing Challenges in India: The New Paradigm Shifts
  Event Type: SYMPOSIUM
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Data Standards Strategy
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Cost Management for Global Drug Development Projects
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Transforming Relationships to Adapt to Evolving Organizational Strategic Goals
  Event Type: SESSION
  Credits: CME, IACET, PMI, RN                                                                      
• Title: Strategic Partnerships: Emerging Models and Their Impact on Drug Development
  Event Type: FORUM
  Credits: CME, IACET, PMI, RN

 

Sign up today to have the latest news in drug development worldwide delivered to your inbox ~ DIA's Global Smartbrief.