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Wednesday, June 21 • 10:30am - 11:45am
#318: IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

The Reagan-Udall Foundation for the FDA will introduce the IMEDS program to facilitate engagement with industry and other researchers to utilize the same tools and methods developed for the FDA's Sentinel System. IMEDS provides the opportunity to leverage expertise and standardized processes for the rapid and robust analysis of regulated products in a post-market setting. The panel will discuss the IMEDS process, characteristics of the IMEDS system as well as an overview of the IMEDS experience.

Learning Objectives

Demonstrate a robust understanding of IMEDS, its capabilities, and characteristics; Discuss broad-use cases as well as potential enhancements to IMEDS


June S. Wasser, MA


Overview of the IMEDS Program
David Martin, MD, MPH

Robert Reynolds, DrSc, MSc, FISPE

Kevin Haynes, PharmD

Jeffrey Brown, PhD


Jeffrey Brown

Associate Professor, Department of Population Medicine, Harvard Pilgrim Health Care Institute/Harvard Medical School
Dr. Brown is an Associate Professor in the Department of Population Medicine, Harvard Medical School and the Harvard Pilgrim Health Care Institute. His primary research activities involve new approaches to facilitate large-scale multi-institutional research and the use of distributed... Read More →
avatar for Kevin Haynes

Kevin Haynes

Director of Clinical Epidemiology, HealthCore Inc.
Kevin Haynes, PharmD, MSCE is a Director of Clinical Epidemiology at HealthCore, Inc. and Adjunct Scholar and an Adjunct Assistant Professor of Epidemiology at the University of Pennsylvania Perelman School of Medicine. He has had extensive collaborations with the FDA and serves as... Read More →
avatar for David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →

Robert Reynolds

Vice President, Epidemiology, Worldwide Safety, Research and Development, Pfizer Inc.
Robert Reynolds is Vice President, Epidemiology at Pfizer. He is also an Adjunct Associate Professor at Tulane & serves on the Board of the International Society for Pharmacoepidemiology (ISPE). He holds degrees from Bard College and the Harvard School of Public Health.
avatar for June Wasser

June Wasser

Executive Director, Reagan-Udall Foundation For the FDA
June Wasser is the Executive Director of the Reagan-Udall Foundation for the FDA and in this role leads the direction of the Foundation and implementation of its programs. She is responsible for building strategic relationships throughout the public-private sector with the goal of... Read More →

Wednesday June 21, 2017 10:30am - 11:45am CDT
S404a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  06: Safety-PV, Session
  • format json
  • Featured Topics Real World Evidence
  • Credit Type CME, IACET, RN
  • Tags Session