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Risk Management Legislation,
Guidance, and Best Practices
October 22, 2008

FEATURED PRESENTATIONS:

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

Plotting a Strategy for the Best Benefit-Risk Ratio
John 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 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 Haas Joanna F. Haas, M.D., M.Sc., Vice President, Pharmacovigilance, Genzyme

Case Study of TYSABRI: RiskMAP Development and Implementation
Carmen 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 Blum Michael 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 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 Resources
Jill 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 Challenges
Robert Reynolds Robert 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.

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