RISK MANAGEMENT PUBLIC WORKSHOP

1. RISK MANAGEMENT PUBLIC WORKSHOP APRIL 9-11, 2003 NTSB BOARD AND CONFERENCE CENTER WASHINGTON, DC

2. RISK MANAGEMENT CDER/CBER EXECUTIVE OVERSIGHT COMMITTEE Steven Galson, Chair Paul Seligman, Vice-Chair Miles Braun, CBER Lead Helen Winkle Jane Axelrad John Jenkins Susan Allen Sandra Kweder Deborah Henderson Susan Ellenberg Rachel Behrman Victor Raczkowski Lee Lemley, Project Manager

3. Risk Management Working Groups • Group I - Risk Assessment - Risk Assessment in Drug and Biologic Development • Group II - Risk Management - Good Risk Management • Group III - Pharmacovigilance - Pharmacoviligance Practices and Pharmacoepidemiologic Assessment

4. Risk Assessment in Drug And Biologic DevelopmentApril 9, 2003AGENDA • 8:00 - 8:15 Welcome and Introductions • 8:15-10:15 Session I - Data Generation FDA Presentation Oral Presentations Panel Discussion and Q&As • 10:15-10:30 Break • 10:30-12:30 Session II - Special Considerations FDA Presentation Oral Presentations Panel Discussion and Q&As Moderator - Deborah Henderson, Director, Office of Executive Programs

5. Risk Assessment in Drug And Biologic DevelopmentApril 9, 2003AGENDA • 12:30- 1:45 LUNCH • 1:45- 3:00 Session III - Data Presentation/Analysis FDA Presentation Oral Presentations • 3:00 - 3:15 BREAK • 3:15 - 4:00 Session III (cont’d) Panel Discussion and Q&As • 4:00 - 4:30 Closing Remarks Moderator - Deborah Henderson, Director, Office of Executive Programs

6. Logistics • Transcripts [Docket 02N-0528] - Available within 30 days after the workshop - Internet Address http://www.fda.gov/ohrms/dockets • Workshop Website Address http://www.fda.gov/cder/meeting/riskmanagement.htm

7. Logistics • No food or drinks are allowed in the conference room • Restrooms are located in the registration lobby area • Note exits from the room