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. Steven Galson, Deputy Director, CDER 4 Pharmacovigilance Practices and Pharmacoepidemiologic Assessment April 11, 2003 AGENDA 8:00 - 8:15Welcome and Introductions 8:00 - 8:15Welcome and Introductions 8:15 - 9:30Session I - Overview and Good Pharmacovigilance Practices 8:15 - 9:30Session I - Overview and Good Pharmacovigilance Practices »FDA Overview/Presentations »Oral Presentations 9:30 - 9:45 Break 9:30 - 9:45 Break 9:45 - 10:00 Speaker - Dr. Mark McClellan, Commissioner, FDA 9:45 - 10:00 Speaker - Dr. Mark McClellan, Commissioner, FDA 10:00 - 11:30Session I (cont’d)10:00 - 11:30Session I (cont’d) »Oral Presentations »Panel Discussion and Q&As

5. Moderator - Dr. Steven Galson, Deputy Director, CDER 5 Risk Management Programs April 10, 2003 AGENDA 11:30 - 1:00Lunch11:30 - 1:00Lunch 1:00 - 2:15Session II - Pharmacoepidemiologic Assessment1:00 - 2:15Session II - Pharmacoepidemiologic Assessment »FDA Presentation »Oral Presentations 2:15 - 2:30BREAK2:15 - 2:30BREAK 2:30 - 4:00Session II (cont’d)2:30 - 4:00Session II (cont’d) »Panel Discussion and Q&As 4:00 - 4:30Closing Remarks4:00 - 4:30Closing Remarks

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