RISK MANAGEMENT PUBLIC WORKSHOPS

1
RISK MANAGEMENT PUBLIC WORKSHOPS

• 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
• Jesse Goodman, 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
• Premarketing Risk Assessment
• Group II - Risk Management
• Risk Management Programs
• Group III - Pharmacovigilance
• Risk Assessment of Observational Data Good
  Pharmacoviligance Practices and
  Pharmacoepidemiologic Assessment

4
Risk Management ProgramsApril 10, 2003AGENDA

• 800 - 815 Welcome and Introductions
• 815- 1000 Session I
• Concepts of Risk Management, when is an RMP
  appropriate?
• Risk Management Tools
• FDA Overview/Presentations Clarification
  Questions
• Oral Presentations
• 1000-1015 Break
• 1015-1200 Session I (contd)
• Oral Presentations (contd)
• Discussion and Questions for Speakers

5
Risk Management ProgramsApril 10, 2003AGENDA

• 1200- 100 Lunch
• 100- 145 Session II -
• Evaluation of Risk Management Programs and
• Elements of a Risk Management Submission
• FDA Presentations/Clarification Questions
• 145- 200 BREAK
• 200 - 400 Session II (contd)
• Oral Presentations
• Discussion and Questions for Speakers
• 400 - 430 Wrap-up, Moderator, Workgroup Chair
  and Co-Leaders

6
Logistics

• Questions for speakers
• Cards being distributed
• Open microphones for clarifications on concept
  papers

7
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/cder/meeting/riskmanagement.htm
  

8
Logistics

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