Post-Approval Drug Safety Strategies
November 12-14, 2008 - The Ritz-Carlton Pentagon City - Arlington, VA
主要演讲:
挑战药物安全性的组织结构及现时间点的观点：关于数据及该领域整体方针
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追求最佳损益比的策略构想
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透过生命周期管理达成药物损益的证据、评价、决策：加拿大保健局的展望及提案
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透过生命周期管理的问题导向安全性评价
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TYSABRI的个案研究：RiskMAP开发及导入
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数据发掘及超越: 质与量的药品安全对策方法集成
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翻译安全生物指标及第1阶段试验方针
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安全科学－我们究竟达到了什么，又朝哪里发展呢？
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组织药物安全评价的资源分配最佳化
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全球性产品危机管理计画：「全员参与」的组织流程、架构及管理
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藉由积极监视改善的药品安全对策：机会与挑战
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掌握公共卫生关键的主体性危机传达及有效管理策略
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Milbhor D'Silva, M.D., Vice President, Product Safety & Pharmacovigilance, Astellas Pharmaceuticals
John Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics
Robyn Lim, Ph.D., Science Advisor, Progressive Licensing Project, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
Joanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme
Carmen Bozic, M.D., Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec Inc.
Michael D. Blum, M.D., M.P.H., Vice President, Global Safety Surveillance and Epidemiology, Wyeth Research
Federico Goodsaid, Ph.D., Associate Director for Operations in Genomics, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
Kasia Petchel, M.D., Vice President, Global Head, Safety Risk Management, Roche
Jill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth
Susan Rosen, M.D., Senior Vice President, Global Pharmacovigilance & Risk Management, Shire Pharmaceuticals
Robert F. Reynolds, Sc.D., Executive Director, Epidemiology Safety and Risk Management, Pfizer Inc.
Cherif Benattia, M.D., Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals, Inc.DISTINGUISED FACULTY:
- Dan Burns, Ph.D., Senior Vice President, Pharmacogenetics, GlaxoSmithKline
- Robert Bader, PharmD, Director of Drug Safety Services, Covance Periapproval Services
- Sean Darcy, Director, Product Safety, MedImmune
- Yola Moride, Ph.D., FISPE, Associate Professor of Pharmacy, Université de Montréal; President, International Society for Pharmacoepidemiology (ISPE)
- Nayan T. Nanavati, Vice President and GM, Peri and Post Approval Research (PACE), Americas, PAREXEL International
- Axel Olsen, Ph.D., Executive Director, Drug Safety and Medical Affairs, Quintiles, Inc.
- Jack A. Reynolds, former-Senior Vice President, R&D, Worldwide Head, Safety Sciences and Comparative Medicine, Pfizer; Chairman, Drug Safety Executive Council (DSEC)
- Peggy Schrammel, Vice President, Clinical Research, Phase IV Development, PharmaNet
- Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management, United BioSource Corporation
- Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance, PharmaNet
- Marcus D. Wilson, Pharm.D., President, HealthCore, a unit of WellPoint, Inc.
- Ashraf F. Youssef, M.D., Associate Medical Director, Pharmacovigilance, Takeda Global R&D
