The Food and Drug Administration Amendments Act of 2007 mandated that the U.S. Food and Drug Administration (FDA) develop a national electronic system to track the safety of regulated medical products. In response, FDA launched the Sentinel Initiative in 2008. Mini-Sentinel, a pilot project of the Sentinel Initiative, uses electronic health care data for postmarket risk identification and analysis of medical product safety.
On February 5, the Engelberg Center for Health Care Reform at Brookings hosted the seventh annual Sentinel Initiative Public Workshop at the Washington Plaza Hotel in Washington, DC. This event served as a forum for leading experts and stakeholders to discuss the current state of the Mini-Sentinel activities; explore stakeholder perspectives on the future of Sentinel; and identify opportunities to expand its use. Dr. Janet Woodcock, the Director of the Center for Drug Evaluation and Research at FDA, provided the morning keynote address.
Further event information and materials are available here.
Janet Woodcock MD, MPH; 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 Institute and Harvard Medical School, Boston, MA
Marsha Reichman PhD; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Michael Nguyen MD; Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD
Karla M. Miller PharmD, BCPP; Hospital Corporation of America, Nashville, TN
Joseph P. Drozda MD; Mercy Health, Chesterfield, MO
Myrl Weinberg CAE; National Health Council, Washington, DC
Sharon F. Terry MA; Genetic Alliance, Washington, DC
Robert F. Reynolds ScD; Pfizer, Inc., New York, NY
Troy McCall PhD; Reagan-Udall Foundation for the FDA, Washington, DC
Marcus D. Wilson PharmD; HealthCore, Wilmington, DE
Rachael L. Fleurence PhD; Patient-Centered Outcomes Research Institute, Washington, DC
David Wheadon MD; AstraZeneca Pharmaceuticals, New York, NY
Claudia Vellozzi MD; Centers for Disease Control and Prevention Division of Viral Hepatitis, Atlanta, GA
Christine K. Cassel MD; National Quality Forum, Washington, DC