Skip to main content
Past Event

Sentinel Initiative Public Workshop

Past Event

State of Mini-Sentinel Activities

Play Video
Now Playing

Stakeholder Perspectives on the Future of the Sentinel System

Play Video
Now Playing

Strengthening Support for Sentinel's Infrastructure through New Uses

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.

twitter logo Join the conversation at @BrookingsMed or #Sentinel

Agenda

Welcome

Strengthening Support for Sentinel's Infrastructure through New Uses

R

Rachael L. Fleurence

Program Director, Comparative Effectiveness Research Methods & Infrastructure - Patient-Centered Outcomes Research Institute

D

David Wheadon

Senior Vice President and Head of Global Regulatory Affairs, Patient Safety and Quality Assurance - AstraZeneca Pharmaceuticals

C

Claudia Vellozzi

Chief, Prevention Branch - Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention

Closing Remarks

Keynote Address

J

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

State of Mini-Sentinel Activities

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

M

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

M

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

R

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

M

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

M

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

K

Karla M. Miller

Assistant VP, Pharmacy Services and Clinical Therapeutics - Hospital Corporation of America, Clinical Services Group

R

Robert F. Reynolds

Vice President and Global Head, Epidemiology in Worldwide Safety - Pfizer, Inc.

T

Troy McCall

Chief Implementation Officer, Innovation in Medical Evidence Development and Surveillance - Reagan-Udall Foundation for the FDA

Lunch

K

Karla M. Miller

Assistant VP, Pharmacy Services and Clinical Therapeutics - Hospital Corporation of America, Clinical Services Group

R

Robert F. Reynolds

Vice President and Global Head, Epidemiology in Worldwide Safety - Pfizer, Inc.

T

Troy McCall

Chief Implementation Officer, Innovation in Medical Evidence Development and Surveillance - Reagan-Udall Foundation for the FDA

More Information

More

Get a weekly events calendar from Brookings