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Committee on the Assessment of the U.S. Drug Safety System
Meeting Two
Open Sessions: July 19-20, 2005
Meeting Location on July 19-20, 2005:
National Academy of Sciences
2101 Constitution Ave, NW (Entrance on C Street)
Washington, DC
Lecture Room
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AGENDA
Tuesday, July 19, 2005
3:00 p.m. - 3:05 p.m.
Welcome and Introductions
David Blumenthal
Sheila Burke
Co-Chairs, Committee on the Assessment of the US Drug Safety System
3:05 p.m. - 6:00 p.m.
Public Comment
Carla Saxton
Professional Affairs Manager
American Society of Consultant Pharmacists
Maryann Napoli
Center for Medical Consumers
John J. Pippin
Physicians Committee for Responsible Medicine
Patrick J. Madden
Lesley Maloney
American Society of Health-System Pharmacists
Marc Wheat
Chief Counsel and Staff Director
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
US House of Representatives
Lindsey Johnson
Consumer Advocate
U.S. Public Interest Research Group (U.S. PIRG)
Alison Rein
Assistant Director
Food & Health Policy National Consumers League
Beth A. McConnell
Director
PennPIRG and the PennPIRG Education Fund
Marion J. Goff
Donald Klein
American College of Neuropsychopharmacology
Tom Woodward
Alliance for Human Resource Protection (AHRP)
State Director, International Coalition of Drug Awareness
(Sign-up to speak at this public comment session was on a first-come basis until the entire three hours were filled)
6:00 p.m.
Adjourn
Wednesday, July 20, 2005
1:00 p.m. - 1:05 p.m.
Welcome and Introductions
David Blumenthal
Sheila Burke
Co-Chairs, Committee on the Assessment of the US Drug Safety System
1:05 p.m. - 3:00 p.m.
Food and Drug Administration's (FDA) Drug Safety Activities
Introduction and Overview
Paul J. Seligman
Director, Office of Pharmacoepidemiology and Statistical Science
Center for Drug Evaluation and Research
Food and Drug Administration
Role of the Office of New Drugs in the Safety Assessment
John K. Jenkins
Director of the Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
The Post-marketing Safety Assessment and the Office of Drug Safety
Anne E. Trontell
Deputy Director, Office of Drug Safety
FDA Center for Drugs
Food and Drug Administration
Future of Safety Assessment
Paul J. Seligman
3:00 p.m. - 3:30 p.m.
Questions from the Committee
3:30 p.m. - 3:45 p.m.
Break
3:45 p.m. - 4:00 p.m.
The Role of the Agency for Healthcare Research and Quality (AHRQ) in the US Drug Safety System
Scott R. Smith
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
4:00 p.m. - 4:30 p.m.
Questions from the Committee
4:30 p.m. - 5:00 p.m.
AHRQ-funded Centers for Education and Research on Therapeutics (CERTs)
And
Contributions of Academia and the Pharmaceutical Industry to Drug Safety Surveillance
Hugh Tilson
Chair, CERTs Steering Committee
5:00 p.m. - 5:30 p.m.
Questions from the Committee
5:30 p.m.
Adjourn
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