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

2. 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. 3 Risk Management Working Groups Group I - Risk AssessmentGroup I - Risk Assessment –Premarketing Risk Assessment Group II - Risk ManagementGroup II - Risk Management –Risk Management Programs Group III - PharmacovigilanceGroup III - Pharmacovigilance –Risk Assessment of Observational Data: Good Pharmacoviligance Practices and Pharmacoepidemiologic Assessment

4. Moderator - Dr. Paul Seligman, Director, OPaSS 4 Risk Management Programs April 10, 2003 AGENDA 8:00 - 8:15Welcome and Introductions 8:00 - 8:15Welcome and Introductions 8:15- 10:00Session I 8:15- 10:00Session I Concepts of Risk Management, when is an RMP appropriate?Concepts of Risk Management, when is an RMP appropriate? Risk Management ToolsRisk Management Tools –FDA Overview/Presentations Clarification Questions –Oral Presentations 10:00-10:15 Break10:00-10:15 Break 10:15-12:00 Session I (cont’d)10:15-12:00 Session I (cont’d) –Oral Presentations (cont’d) –Discussion and Questions for Speakers

5. Moderator - Dr. Paul Seligman, Director, OPaSS 5 Risk Management Programs April 10, 2003 AGENDA 12:00- 1:00Lunch12:00- 1:00Lunch 1:00- 1:45Session II -1:00- 1:45Session II - Evaluation of Risk Management Programs andEvaluation of Risk Management Programs and Elements of a Risk Management SubmissionElements of a Risk Management Submission –FDA Presentations/Clarification Questions 1:45- 2:00BREAK1:45- 2:00BREAK 2:00 - 4:00Session II (cont’d)2:00 - 4:00Session II (cont’d) –Oral Presentations –Discussion and Questions for Speakers 4:00 - 4:30Wrap-up, Moderator, Workgroup Chair and Co-Leaders4:00 - 4:30Wrap-up, Moderator, Workgroup Chair and Co-Leaders

6. 6 Logistics Questions for speakersQuestions for speakers –Cards being distributed –Open microphones for clarifications on concept papers

7. 7 Logistics Transcripts [Docket 02N-0528] - Available within 30 days after the workshop - Internet Address http://www.fda.gov/ohrms/docketsTranscripts [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.htmWorkshop Website Address http://www.fda.gov/cder/meeting/riskmanagement.htm

8. 8 Logistics No food or drinks are allowed in the conference roomNo food or drinks are allowed in the conference room Restrooms are located in the registration lobby areaRestrooms are located in the registration lobby area Note exits from the roomNote exits from the room