11:10

Premarket Notification: Analysis of FDA Recall Data

William H. Maisel, Director, Medical Device Safety Institute

11:50

FDA Recall Data Study

Ralph Hall, Distinguished Visiting Professor of Law, University of Minnesota Law School

12:30 PM

Lunch

 

Non-FDA Sources of Adverse Event Data

1:30

The National Cardiovascular Data Registries: Opportunities and Challenges in Postmarket Surveillance

Frederick A. Masoudi, MD, MSPH, Associate Professor of Medicine, Denver Health Medical Center & University of Colorado; Senior Medical Officer, National Cardiovascular Data Registries

2:00

The VA-CART Program: Integration of Real-Time Data Collection into the Process of Clinical Care

Paul D. Varosy, Director of Cardiac Electrophysiology, VA Eastern Colorado Health Care System, Project Director, CART-EP, and Assistant Professor of Medicine, University of Colorado Denver

2:30

The Centers for Education and Research on Therapeutics (CERTs) Program

Eric D. Peterson, Fred Cobb MD Distinguished Professor of Medicine and Associate Director of the Duke University Medical Center, and Director CV Research of the Duke Clinical Research Institute

3:00

Automated Postmarket Safety Surveillance: The DELTA Surveillance Project

Frederic S. Resnic, Director, Cardiac Catheterization Laboratory Brigham and Women’s Hospital, and Assistant Professor of Medicine, Harvard Medical School

3:30

Break



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