| John
Ferguson, M.D., Vice President,
Pharmacovigilance, Millennium Pharmaceuticals, Inc.
Jill Robinson, R.Ph., MBA, Vice President, Global SafetySurveillance & Epidemiology,
Wyeth
Mansoor A. Khan, R.Ph., Ph.D., Director, Division
of Product Quality Research, FDA
Robert G. Sharrar, M.D., M.Sc., Executive Director,
Clinical Risk Management & Safety Surveillance, Merck & Co.,
Inc.
Lucette Doessegger, M.D., Drug Safety, Global
Head Licensing and Early Development, F. Hoffmann-La Roche AG
Andrew Branca, Senior Vice President, Drug Safety
Risk Management, Cambridge Healthtech Associates
Atsuko Shibata, M.D., Ph.D., MPH, Director, Global
Safety, Amgen Inc.
Andrew Rut, M.D., Lead Physician and VP Global Safety &
Pharmacovigilance, GlaxoSmithKline
Bennett Levitan, M.D., Ph.D., Associate Director,
Portfolio Planning, Johnson & Johnson Pharmaceutical Research &Development,
L.L.C.
Chuen Yee, M.D., Senior Director, Surveillance,Epidemiology and Biostatistics, Benefit-Risk
Management, Johnson & Johnson Pharmaceutical Research &Development,
L.L.C.
Patrick M. Caubel, M.D., MBA, AVP, Head
of Pharmacovigilance North America, sanofi-pasteur
Joanna L. C. May, Business Alliance Consultant, Global Product Safety, Eli Lilly and Company
Kimberly Thompson, M.S., Sc.D., Associate Professor
of Risk Analysis and Decision Science, Harvard School of Public
Health, MIT Sloan School of Management, and Author of‘ 'Risk in
Perspective’
Gerald Faich, MD, MPH, FISPE,
Senior Vice President Epidemiology & Risk Management, United
BioSource Corporation
Annette Stemhagen,
DrPH, FISPE, Vice President
Epidemiology & Risk Management, United BioSource
Corporation
John Clark, MD,
MSPH, Senior Director, Epidemiology & Risk Management,
United BioSource Corporation
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A Quality by Design Approach to
Product/Process Understanding and Post Approval Safety
Mansoor A. Khan, R.Ph., Ph.D., Director, Division of Product
Quality Research, FDA
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The Art and Science of Balancing Benefit and Risk
John Ferguson, M.D., Vice President, Pharmacovigilance, Millennium Pharmaceuticals, Inc. |
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Establishing and Sustaining a Proactive Drug Safety Risk Management System
Jill Robinson, R.Ph., MBA, Vice President, Global Safety Surveillance & Epidemiology, Wyeth |
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- Implementing programs that increase the probability of timely approval and mitigate safety risks
- Aligning resources to design and execute a proactive risk management plan
- Integrating drug safety knowledge longitudinally across a compound’s lifecycle
- Optimizing the allocation of an organization’s drug safety assessment resources
- Understanding regulatory authorities’ evolving drug safety risk management expectations
- Utilizing quantitative approaches for surveillance and signal detection in pharmacovigilance
- Driving your business for the best benefit-risk
ratio
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