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Past Event

Expert Workshop: Statistical and Epidemiological Issues in Active Medical Product Surveillance

The U.S. Food and Drug Administration (FDA) is developing the capacity for active medical product surveillance, which will enhance the agency’s ability to monitor the safety of marketed medical products. This new capacity will come in the form of the Sentinel System, which is currently being piloted through a project known as Mini-Sentinel. Accomplishing the goals of active medical product surveillance will require further development of new and existing methods and tools.

On February 16, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss some of the most pressing methodological issues facing active medical product safety surveillance. At this workshop, experts from academia, the private sector, FDA and other government agencies discussed several topics, including:

  • Appropriate analysis and interpretation of signals in the context of large sample sizes
  • Analyzing horizontally and vertically partitioned data
  • Evaluating the performance of active surveillance methods



Welcome, Introduction, and Meeting Objectives

Opening Remarks


Rachel Behrman

Director, Office of Medical Policy, Center for Drug Evaluation and Research


Judy Racoosin

Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research

Session I: Signal Refinement in the Context of Large Sample Sizes

Session II: Meta-Analytic Approaches for Combining Multiple Results to the Same Query

Session III: Distributed Regression and Related Methods for Signal Refinement


Bradley Malin

Vanderbilt University School of Medicine and School of Engineering

Session IV: Establishing Operating Characteristics of Active Surveillance Approaches

Recap and Closing Remarks

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