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Vaccine Safety Research, Data Access, and Public Trust Appendix E Meeting Two—Agenda The National Academies Institute of Medicine Committee on Review of NIP’s Research Procedures and Data Sharing Program Meeting Two AGENDA Speakers and Times Subject to Change Thursday, October 21, 2004 9:00 a.m. – 5:30 p.m. Meeting Location: Keck Center of the National Academies Room 100 500 Fifth Street, NW Washington, DC 20001 8:30–9:00 a.m. Registration and Coffee
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Vaccine Safety Research, Data Access, and Public Trust 9:00–9:15 a.m. Welcome, Introductions, and Opening Statement John Bailar, MD, PhD Committee Chair 9:15–9:35 a.m. Charge to the Committee—Second Component of Charge Roger Bernier, PhD, MPH Senior Advisor for Scientific Strategy and Innovation National Immunization Program Centers for Disease Control and Prevention 9:35–9:50 a.m. Questions from the Committee 9:50–10:10 a.m. A Peer-Reviewed Journal’s Perspective on the Release of Preliminary Findings Harold Sox, MD Editor Annals of Internal Medicine American College of Physicians of Internal Medicine 10:10–10:25 a.m. Questions from the Committee 10:25–10:40 a.m. Break 10:40–11:00 a.m. When to Release Preliminary Findings: Ethical Considerations Charles Weijer, MD, PhD, FRCPC CIHR Investigator Associate Professor of Bioethics, Medicine, and Surgery Adjunct Professor of Philosophy Department of Bioethics Dalhousie Medical School 11:00–11:15 a.m. Questions from the Committee
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Vaccine Safety Research, Data Access, and Public Trust 11:15–11:35 a.m. Communicating Health Risks Identified Through Preliminary Analyses Katherine McComas, PhD Assistant Professor Department of Communication Cornell University 11:35–11:50 a.m. Questions from the Committee 11:50–12:10 p.m. When to Release Preliminary Findings: Post-Market Surveillance of Medical Devices Susan Gardner, PhD Director, Office of Surveillance Biometrics Center for Devices and Radiological Health Food and Drug Administration 12:10–12:25 p.m. Questions from the Committee 12:25–1:30 p.m. Lunch (Cafeteria on 3rd Floor; List of nearby restaurants in folder) 1:30–2:00 p.m. VSD Studies that Utilized Iterative Analyses Frank DeStefano, MD, MPH Medical Epidemiologist National Immunization Program Centers for Disease Control and Prevention 2:00–2:15 p.m. Questions from the Committee 2:15–2:35 p.m. Statistical Methods and Issues Relevant to Iterative Analyses David DeMets, PhD Professor and Chair Department of Biostatistics and Medical Informatics University of Wisconsin-Madison 2:35–2:50 p.m. Questions from the Committee
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Vaccine Safety Research, Data Access, and Public Trust 2:50–3:10 p.m. Use of Preliminary Findings for Policy Decisions: The Rotavirus Vaccine Experience Melinda Wharton, MD, MPH Acting Deputy Director National Immunization Program Centers for Disease Control and Prevention 3:10–3:25 p.m. Questions from the Committee 3:25–3:40 p.m. Break 3:40–4:00 p.m. Advocacy Group Perspective on Criteria for Releasing Preliminary Findings Sallie Bernard Executive Director and Co-Founder SafeMinds 4:00–4:15 p.m. Questions from the Committee 4:15–4:35 p.m. Pediatricians’ Perspective on Preliminary Findings as Evidence for Decision-Making Julia McMillan, MD Professor of Pediatrics Vice Chair for Pediatric Education Johns Hopkins University School of Medicine 4:35–4:50 p.m. Questions from the Committee 4:50–5:20 p.m. Public Comment (A sign-up sheet will be available at the registration table) 5:20–5:30 p.m. Closing Remarks John Bailar, MD, PhD Committee Chair
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