Past Event

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

D

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

9:10 AM -- Keynote Address

9:40 AM -- Sentinel Today: FDA Perspective

D

Rachel Behrman

Director, Office of Medical Policy, Center for Drug Evaluation and Research

S

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

P

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

1:15 PM -- Session II: Perspectives from the Stakeholder Community

N

Diana Zuckerman

National Research Center for Women & Families/Cancer Prevention and Treatment Fund

S

Dan Troy

Senior Vice President and General Counsel

3:00 PM -- Session III: Sentinel as a National Resource for Evidence Development

D

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

E

Sam Nussbaum

Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc.

4:30 PM -- Closing Remarks

More Information

Contact
Engelberg Center for Health Care Reform
(202)797-4391

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