Agenda: Meeting 2
Thursday, October 21, 2004
9:00 a.m. - 5:30 p.m.
8:30 - 9:00 a.m.
Registration and Coffee
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
11:15 -11:35 a.m.
Communicating Health Risks Identified Through Preliminary Analyses
Katherine McComas, PhD
Assistant Professor
Department of Communication
Cornell University
PowerPoint Presentation
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
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
5:20 - 5:30 p.m.
Closing Remarks
John Bailar, MD, PhD
Committee Chair
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