Third Annual Sentinel Initiative Public Workshop
In May 2008, the U.S. Food and Drug Administration (FDA) unveiled the Sentinel Initiative – a national electronic data system designed to track the safety of drugs, biologics, and medical devices in the United States. Since that time, FDA has engaged key stakeholders to address technical and policy issues that are critical to the initiative’s success.
On January 12, the Engelberg Center for Health Care Reform hosted the third annual Sentinel Initiative public workshop, bringing together the stakeholder community for a discussion on a variety of topics in active medical product surveillance, including an update on Mini-Sentinel, the testing mechanism and coordinating center for the Sentinel Initiative; near-term plans for the Sentinel Initiative; and opportunities for coordination with other Department of Health and Human Services efforts that use distributed systems of automated health care data.
Read The New England Journal of Medicine article, “Developing the Sentinel System – A National Resource for Evidence Development.”
Agenda
9:00 AM -- Welcome
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
9:10 AM -- Keynote Address
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
9:40 AM -- Sentinel Today: FDA Perspective
Rachel Behrman
Director, Office of Medical Policy, Center for Drug Evaluation and Research
Judy Racoosin
Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research
10:00 AM -- Session I: Mini-Sentinel Accomplishments and Plans for Year Two
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Lesley Huntley Curtis
Associate Professor in Medicine - Duke University School of Medicine
Kristen B. Rosati
Coppersmith Schermer & Brockelman PLC
1:15 PM -- Session II: Perspectives from the Stakeholder Community
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Kathleen Jaeger
Vice President and Chief Executive Officer
Myrl Weinberg
Chief Executive Officer - National Health Council
Diana Zuckerman
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
Dan Troy
Senior Vice President and General Counsel
J. Leonard Lichtenfeld
Deputy Chief Medical Officer, American Cancer Society
3:00 PM -- Session III: Sentinel as a National Resource for Evidence Development
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Sherry Glied
Nonresident Senior Fellow - Economic Studies, USC-Brookings Schaeffer Initiative for Health Policy
Moderator: Reed Tuckson
UnitedHealth Group
Sam Nussbaum
Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc.
4:30 PM -- Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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