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.
Rachel Behrman , MD, MPH, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Judy Racoosin, MD, MPH, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Richard Platt, MD, MSc, Department of Population Medicine, Harvard Pilgrim Healthcare and Harvard Medical School, Boston, MA;
Lesley Curtis, PhD, Duke University School of Medicine, Durham, NC
Kristin Rosati, JD, Coppersmith Schermer and Brockelman PLC, Phoenix, AZ
Bruce Fireman, MS, Kaiser Permanente, Northern California, Oakland, CA