Risk Management Public Workshop - Day 1
Risk Assessment in Drug and Biologic Development

April 9, 2003

AGENDA (updated 4/7/2003)

Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologic Evaluation and Research (CBER)

Moderator: 
Deborah Henderson, Director, Office of Executive Programs, CDER

8:00 - 8:15 

Welcome and Introductions
Dr. Steven Galson, Deputy Director, CDER

8:15 - 10:15 

Session I -- Data Generation

• FDA Presentation - Dr. Robert J. Meyer, Director, Office of Drug Evaluation II, CDER
• Oral Presentations - Public Comment (preregistered)
  • Glenn Gormley, M.D, Ph.D., AstraZeneca, PhRMA
  • Judith Jones, M.D., Ph.D., The Degge Group for the International Society for Pharmacoepidemiology
  • Joanna Haas, M.D., MSc., Genzyme Corporation, Biotechnology Industry Organization
• Panel Discussion and Q&As

10:15 - 10:30  Break

10:30 - 12:30 

Session II - Special Considerations

FDA Presentation - Dr. Robert Temple, Director, Office of Drug Evaluation I, CDER

• Oral Presentations - Public Comment (preregistered)
  • Dr. Gary Stein, American Society of Health-System Pharmacists
  • Michael R. Cohen, RPh, MS, ScD, Institute for Safe Medication Practices
  • Penelope K. Manasco, M.D., First Genetic Trust
  • Anshu Vashishtha, M.D., Ph.D., Watson Pharmaceuticals
• Panel Discussion and Q & As

12:30 - 1:45  Lunch

1:45 - 3:00 

Session III - Data Presentation/Analysis

• FDA Presentation - Dr. Ellis Unger, Division of Clinical Trial Design and Analysis, CBER
• Oral Presentations - Public Comment (preregistered)
  • Christy Chaung-Stein, Ph.D., Pharmaceia, PhRMA
  • Dr. Sidney Kahn, Pharmacovigilance & Risk Management, Inc.

3:00 - 3:15  Break

Oral Presentations (cont'd) - Public Comment (preregistered)

• Dr. Paul Stolley, Public Citizen Health Research Group, 

Panel Discussion and Q & As

4:00 - 4:30  Closing Remarks - Dr. Robert Meyer

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FDA/Center for Drug Evaluation and Research
Posted: March 5, 2003, Updated April 7, 2003
Originator: OTCOM/DLIS
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