RISK MANAGEMENT PUBLIC WORKSHOP

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RISK MANAGEMENT PUBLIC WORKSHOP

• APRIL 9-11, 2003
• NTSB BOARD AND CONFERENCE CENTER
• WASHINGTON, DC

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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

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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

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Risk Assessment in Drug And Biologic
DevelopmentApril 9, 2003AGENDA

• 800 - 815 Welcome and Introductions
• 815-1015 Session I - Data Generation FDA
  Presentation Oral Presentations Panel
  Discussion and QAs
• 1015-1030 Break
• 1030-1230 Session II - Special
  Considerations FDA Presentation Oral
  Presentations Panel Discussion and QAs

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Risk Assessment in Drug And Biologic
DevelopmentApril 9, 2003AGENDA

• 1230- 145 LUNCH
• 145- 300 Session III - Data Presentation/Analysi
  s FDA Presentation Oral Presentations
• 300 - 315 BREAK
• 315 - 400 Session III (contd) Panel
  Discussion and QAs
• 400 - 430 Closing Remarks

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Logistics

• Transcripts Docket 02N-0528 - Available
  within 30 days after the workshop -
  Internet Address http//www.fda.gov/ohrms/do
  ckets
• Workshop Website Address http//www.fda.gov/cde
  r/meeting/riskmanagement.htm

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Logistics

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