Post-Approval Drug Safety Strategies
November 12-14, 2008 - The Ritz-Carlton Pentagon City - Arlington, VA
主要演講:
挑戰藥物安全性的組織結構及現時間點的觀點：關於資料及該領域整體方針
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追求最佳損益比的策略構想
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透過生命週期管理達成藥物損益的證據、評價、決策：加拿大保健局的展望及提案
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透過生命週期管理的問題導向安全性評價
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TYSABRI的個案研究：RiskMAP開發及導入
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資料發掘及超越: 質與量的藥品安全對策方法整合
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翻譯安全生物指標及第1階段試驗方針
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安全科學－我們究竟達到了什麼，又朝哪裡發展呢？
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組織藥物安全評價的資源分配最佳化
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全球性產品危機管理計畫：「全員參與」的組織流程、架構及管理
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藉由積極監視改善的藥品安全對策：機會與挑戰
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掌握公共衛生關鍵的主體性危機傳達及有效管理策略
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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
