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Distinguished Presenters and Panelists:

Michael D. Blum, M.D., M.P.H., Vice President, Global Safety Surveillance and Epidemiology, 
Wyeth Research
J. David Haddox, DDS, M.D., Vice President, Risk Management & Health Policy,
Purdue Pharma L.P. Purdue Pharma L.P.
Daniel K. Burns, Ph.D., Senior Vice President, Therapeutic Matrix, Compliance and Pharmacovigi-lance,
GlaxoSmithKline
Alexander Ommaya, Sc.D., Director, Translational Research, Office of Research and Development,
US Department of Veterans Affairs
Vikram Dev, M.D., Vice President, Head of Drug Safety,
AstraZeneca
Judith M. Sills, PharmD, Vice President and Head, Medical Safety Operations, Integrated Medical Safety,
Novartis Pharmaceuticals 
John Ferguson, M.D., Vice President, Pharmacovigilance,
Millennium Pharmaceuticals, Inc.
Sean Zhao, M.D., Ph.D., Executive Director, Global Safety,
Amgen, Inc.
• Carmen Castaneda, M.D., Senior Medical Reviewer, Worldwide Drug Safety, 
Celgene Corporation
• Uwe Maennl, Vice President and Global Head Pharmacovigilance,
PAREXEL
• 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
• Donald B. Chalfin, M.D., Associate Professor of Epidemiology, Albert Einstein College of Medicine and Chief Scientific Officer,
Analytica International
• Peggy Schrammel, Executive Director, Late Phase Development,
PharmaNet
• Fran Cunningham, PharmD, Director, Center for Medication Safety, Veterans Health Administration,
US Department of Veterans Affairs
• Eleanor S. Segal, M.D., Vice President and Head, Global Drug Safety, 
Actelion Pharmaceuticals Ltd.
• Gerald Faich, M.D., MPH, FISPE, Senior Vice President, Epidemiology and Risk Management,
United Bio-Source Corporation
• Robert G. Sharrar, M.D., M.Sc., Executive Director, Clinical Risk Management & Safety Surveillance,
Merck & Co., Inc.
• Alan Goldberg, R.Ph., Director, Drug Safety Services, Periapproval,
Covance, Inc.
• Annette Stemhagen, DrPH, FISPE, Vice President, Epidemiology and Risk Management,
United BioSource Corporation
• Nilima Justice, M.D., Senior Director Product Safety Surveillance,
Novo Nordisk, Inc.
• Jan Willem van der Velden, M.D., Senior Vice President, Global Safety and Pharmacovigilance,
PharmaNet
• Vivek Kadambi, Director, Drug Safety Evaluation,
Millennium Pharmaceuticals, Inc.

Presentations, In-Depth Case
Studies, and Interactive Panels…

  • Integrating drug safety knowledge across a compound’s lifecycle 
  • Structured benefit-risk balance: Update on industry initiatives
  • Risk management in early development: The preclinical/clinical safety feedback loop
  • Decreasing liability and improving brand by employing a proactive communication and risk management strategy
  • The other side of the benefit-risk ratio: Outcomes research as a means of demonstrating product benefit
  • Leveraging drug registry tools to assess safety and performance
  • Embracing the shifting paradigm from post- to pre-approval safety

Inclusive Pre-Conference Case 
Study-Based Workshop:

Identifying and Managing Pharmacovigilance Risk with a Business Partner

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