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.”
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Associate Professor in Medicine - Duke University School of Medicine
Coppersmith Schermer & Brockelman PLC
Vice President and Chief Executive Officer
Chief Executive Officer - National Health Council
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
Senior Vice President and General Counsel
Deputy Chief Medical Officer, American Cancer Society
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
Assistant Secretary for Planning and Evaluation
Executive Vice President, Clinical Health Policy and Chief Medical Officer - WellPoint, Inc.
To subscribe or manage your subscriptions to our top event topic lists, please visit our event topics page.