Sentinel Initiative Public Workshop
Past Event
State of Mini-Sentinel Activities
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.
Join the conversation at @BrookingsMed or #Sentinel
Agenda
Welcome
Strengthening Support for Sentinel's Infrastructure through New Uses
Marcus D. Wilson
President - HealthCore
Rachael L. Fleurence
Program Director, Comparative Effectiveness Research Methods & Infrastructure - Patient-Centered Outcomes Research Institute
David Wheadon
Senior Vice President and Head of Global Regulatory Affairs, Patient Safety and Quality Assurance - AstraZeneca Pharmaceuticals
Claudia Vellozzi
Chief, Prevention Branch - Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention
Christine K. Cassel
President and CEO - National Quality Forum
Closing Remarks
Keynote Address
Janet Woodcock
Director, Center for Drug Evaluation and Research - US Food and Drug Administration
State of Mini-Sentinel Activities
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Marsha E. Reichman
Senior Advisor and Scientific Lead for Surveillance Programs - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administraion
Michael D. Nguyen
Deputy Director, Division of Epidemiology, Office of Biostatistics and Epidemiology - Center for Biologics Evaluation and Research, US Food and Drug Administration
Break
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Marsha E. Reichman
Senior Advisor and Scientific Lead for Surveillance Programs - Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administraion
Michael D. Nguyen
Deputy Director, Division of Epidemiology, Office of Biostatistics and Epidemiology - Center for Biologics Evaluation and Research, US Food and Drug Administration
Stakeholder Perspectives on the Future of the Sentinel System
Karla M. Miller
Assistant VP, Pharmacy Services and Clinical Therapeutics - Hospital Corporation of America, Clinical Services Group
Joseph P. Drozda
Director of Outcomes Research - Mercy Health
Myrl Weinberg
Chief Executive Officer - National Health Council
Sharon F. Terry
President and Chief Executive Officer - Genetic Alliance
Robert F. Reynolds
Vice President and Global Head, Epidemiology in Worldwide Safety - Pfizer, Inc.
Troy McCall
Chief Implementation Officer, Innovation in Medical Evidence Development and Surveillance - Reagan-Udall Foundation for the FDA
Lunch
Karla M. Miller
Assistant VP, Pharmacy Services and Clinical Therapeutics - Hospital Corporation of America, Clinical Services Group
Joseph P. Drozda
Director of Outcomes Research - Mercy Health
Myrl Weinberg
Chief Executive Officer - National Health Council
Sharon F. Terry
President and Chief Executive Officer - Genetic Alliance
Robert F. Reynolds
Vice President and Global Head, Epidemiology in Worldwide Safety - Pfizer, Inc.
Troy McCall
Chief Implementation Officer, Innovation in Medical Evidence Development and Surveillance - Reagan-Udall Foundation for the FDA
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