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.
Strengthening Support for Sentinel's Infrastructure through New Uses
1:45 pm - 3:00 pmRachael L. Fleurence Program Director, Comparative Effectiveness Research Methods & Infrastructure - Patient-Centered Outcomes Research InstituteDavid Wheadon Senior Vice President and Head of Global Regulatory Affairs, Patient Safety and Quality Assurance - AstraZeneca PharmaceuticalsClaudia Vellozzi Chief, Prevention Branch - Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention
9:15 am - 9:30 am
State of Mini-Sentinel Activities
9:30 am - 11:00 am
11:00 am - 11:15 am
Stakeholder Perspectives on the Future of the Sentinel System
11:15 am - 12:45 pm
12:45 pm - 1:45 pm