Challenging Organizational Structure and Current Thinking in Drug Safety: Taking a Holistic Approach to Data and DepartmentsMilbhor D'Silva, M.D., Vice President, Product Safety & Pharmacovigilance, Astellas Pharmaceuticals
Plotting a Strategy for the Best Benefit-Risk RatioJohn Ferguson, M.D., Ph.D., Vice President & Global Head, Pharmacovigilance & Medical Safety, Novartis Vaccines & Diagnostics
Drug Benefit-Risk Evidence, Assessment and Decision-Making Across Life-Cycle: Health Canada Perspective and ProposalRobyn Lim, Ph.D., Science Advisor, Progressive Licensing Project, Therapeutic Products Directorate, Health Products and Food Branch, Health Canada
Problem Oriented Safety Evaluation through the Life CycleJoanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme
Case Study of TYSABRI: RiskMAP Development and ImplementationCarmen Bozic, M.D., Vice President and Global Head, Drug Safety and Risk Management, Biogen Idec Inc.
Data Mining and Beyond: The Integration of Qualitative and Quantitative Pharmacovigilance MethodsMichael D. Blum, M.D., M.P.H., Vice President, Global Safety Surveillance and Epidemiology, Wyeth Research
Translational Safety Biomarkers and the Path to Phase-1 StudiesFederico 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
Safety Sciences - How Far Have we Come and Where are we Heading?Kasia Petchel, M.D., Vice President, Global Head, Safety Risk Management, Roche
Optimizing the Allocation of an Organization's Drug Safety Assessment ResourcesJill Robinson, R.Ph., M.B.A., Vice President, Global Safety Surveillance & Epidemiology, Wyeth
Global Product Risk Management Planning: Organizational Process, Structure and Governance for Getting ‘All Hands on Board’Susan Rosen, M.D., Senior Vice President, Global Pharmacovigilance & Risk Management, Shire Pharmaceuticals
Improving Pharmacovigilance through Active Surveillance: Opportunities and ChallengesRobert F. Reynolds, Sc.D., Executive Director, Epidemiology Safety and Risk Management, Pfizer Inc.
Proactive Risk Communication as Key to Public Health and Pharmaceutical Risk Benefit Management Strategy Cherif Benattia, M.D., Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals, Inc.
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