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IMEDS: A Public-Private Partnership to Facilitate Real World Evidence Generation Based on the FDA's Sentinel System
Session Chair(s)
June Wasser, MA
Executive Director
Reagan-Udall Foundation For the FDA, United States
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 Objective : Demonstrate a robust understanding of IMEDS, its capabilities, and characteristics; Discuss broad-use cases as well as potential enhancements to IMEDS
Speaker(s)
Overview of the IMEDS Program
David Martin, MD, MPH
Novartis, United States
Vice President, Head, PCO Center of Excellence
Panelist
Robert Reynolds, DRSC, MSC, FISPE
Pfizer Inc, United States
Vice President, Epidemiology, Worldwide Regulatory and Safety
Panelist
Kevin Haynes, PHARMD
HealthCore Inc., United States
Director of Clinical Epidemiology
Panelist
Jeffrey Brown, PHD, MA
Harvard Pilgrim Health Care Institute/Harvard Medical School, United States
Associate Professor, Department of Population Medicine