Post-Approval Drug Safety Strategies

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Challenging Organizational Structure and Current Thinking in Drug Safety: Taking a Holistic Approach to Data and Departments
Milbhor D'SilvaMilbhor D'Silva, M.D., Vice President, Product Safety & Pharmacovigilance, Astellas Pharmaceuticals



Plotting a Strategy for the Best Benefit-Risk Ratio
John FergusonJohn 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 Proposal
Robyn LimRobyn 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 Cycle
Joanna HaasJoanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme


Case Study of TYSABRI: RiskMAP Development and Implementation
Carmen BozicCarmen 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 Methods
Michael BlumMichael 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 Studies
Federico GoodsaidFederico 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 PetchelKasia Petchel, M.D., Vice President, Global Head, Safety Risk Management, Roche


Optimizing the Allocation of an Organization's Drug Safety Assessment Resources
Jill RobinsonJill 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 RosenSusan Rosen, M.D., Senior Vice President, Global Pharmacovigilance & Risk Management, Shire Pharmaceuticals


Improving Pharmacovigilance through Active Surveillance: Opportunities and Challenges
Robert ReynoldsRobert 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 BenattiaCherif Benattia, M.D., Vice President, Pharmacovigilance & Public Health, Vertex Pharmaceuticals, Inc.



  • 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
  • Bob Sharrar, M.D., MSc, BA, Executive Director, Epidemiology and Risk Management, United BioSource Corporation

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