INSTITUTE OF MEDICINE
COMMITTEE ON POSTMARKET SURVEILLANCE OF PEDIATRIC MEDICAL DEVICES
National Academies Building
500 Fifth Street NW, Room 204
Washington, DC

OPEN SESSION AGENDA

Thursday, April 15 - Room 204 

1:00    Welcome and introductions

1:10    FDA Context and Perspectives

• Donna-Bea Tillman, Ph.D.
  Deputy Director, Office of Device Evaluation
  Center for Devices and Radiologic Health
  Food and Drug Administration
  
• Thomas Gross, M.D.
  Director, Division of Postmarket Surveillance
  Center for Devices and Radiologic Health
  Food and Drug Administration

2:40    Break

3:00    Research on Postmarket Surveillance: Experience of Duke Center for Education and Research on Therapeutics

• Judith M. Kramer, M.D.
  Principal Investigator
  Duke Center for Education and Research on Therapeutics

4:00    Analysis of FDA Adverse Event Reports

• Mark Bruley
  Vice President, ECRI (committee member) 

5:15    Adjourn