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Appendix A Study Origins and Activities
Pages 279-287

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From page 279...
... Appendixes 279
From page 281...
... to conduct a study of postmarket surveillance of pediatric medical devices. IOM appointed a committee of 13 experts to oversee the study.
From page 282...
... The agendas and participants for the public meetings are listed below. INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Room 204, The Keck Center, National Academy of Sciences 500 Fifth Street NW, Washington, DC Public Session -- April 15, 2004 1:00 Welcome and introductions 1:10 FDA Context and Perspectives Donna-Bea Tillman, Ph.D.
From page 283...
... APPENDIX A 283 INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Room 100, The Keck Center, National Academy of Sciences 500 Fifth Street NW, Washington, DC Public Session -- June 24, 2004 1:00 Welcome and introductions 1:10 Update from CDRH/FDA: Thomas Gross, M.D. Briefing on Legislative Interest in Pediatric Medical Devices: Vipul Mankad, M.D.
From page 284...
... Bright, Sc.D. Epidemiologist Division of Postmarket Surveillance Office of Surveillance and Biometrics Center for Devices and Radiological Health U.S.
From page 285...
... APPENDIX A 285 INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Lecture Room, National Academy of Sciences 2101 Constitution Avenue, NW, Washington, DC Public Session -- August 31, 2004 8:20 Welcome 8:30 Advanced Medical Technology Association Susan Alpert, M.D. Vice President, Chief Quality and Regulatory Officer Medtronic Minneapolis, MN 9:00 American College of Cardiology, Congenital Heart Disease and Pediatric Cardiology Committee Mark Boucek, M.D.
From page 286...
... * INSTITUTE OF MEDICINE Committee on Postmarket Surveillance of Pediatric Medical Devices Lecture Room, National Academy of Sciences 2101 Constitution Avenue, NW, Washington, DC Public Session -- August 31, 2004 (afternoon)
From page 287...
... INTRODUCTION 287 Donya Hartley Melisande Statz-Hill and Benjamin Hill Penny Hill and Amanda Hill Kim L Katka Karen Marston


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