INSTITUTE OF MEDICINE
COMMITTEE ON POSTMARKET SURVEILLANCE
OF PEDIATRIC MEDICAL DEVICES
500 Fifth Street NW, Room 100
Washington, DC

JUNE 24, 1004 - OPEN SESSION AGENDA

 1:00    Welcome and introductions  

 1:10    Update from CDRH/FDA: Thomas Gross, M.D. 

            Briefing on legislative interest in pediatric medical devices: Dr. Vipul Mankad (RWJF fellow with Senate Health, Education, Labor and Pensions Committee) 

1:30    Discussion with Clinical Advisory Panel 

Jonathan Abramson, M.D.
Professor and Chair, Department of Pediatrics
Wake Forest University

Francis Sessions Cole, III, M.D.
Vice Chair and Park J. White Professor of Pediatrics
Washington University School of Medicine
Director, Division of Newborn Medicine
St. Louis Children's Hospital

Barbara Fivush, M.D.
Professor of Pediatrics
The Johns Hopkins School of Medicine
Division Chief, Pediatric Nephrology
The Johns Hopkins Hospital

Susan T. Iannaccone, MD, FAAN
Director, Neuromuscular Disease and Neurorehabilitation
Texas Scottish Rite Hospital for Children
Professor of Neurology
UT Southwestern Medical Center

John K. Niparko, M.D.
George T. Nager Professor
Director, Division of Otology, Neurotology & Skull Base Surgery
The Johns Hopkins School of Medicine

Ramon L. Ruiz, D.M.D., M.D.
Assistant Professor, Oral/Maxillofacial Surgery & Pediatrics
Director, Pediatric Oral/Maxillofacial Surgery
University of North Carolina, Chapel Hill

Frederick J. Schoen, M.D., Ph.D.
Professor of Pathology and Health Sciences and Technology
Harvard Medical School
Executive Vice Chairman, Department of Pathology
Brigham and Women’s Hospital

3:45    Break 

4:00    Discussion with Methods Advisory Panel

Elizabeth B. Andrews, Ph.D., M.P.H.
Vice PresidentPharmacoepidemiology and Risk Management
RTI Health Solutions

Roselie A. Bright, Sc.D.
Epidemiologist
Division of Postmarket Surveillance
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration

Robert T. Chen, M.D., M.A.
Chief, Immunization Safety Branch
National Immunization Program
Centers for Disease Control and Prevention

Harry A. Guess, M.D., Ph.D.
Professor of Epidemiology
School of Public Health
University of North Carolina at Chapel Hill

5:00    Adjourn