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REMS Integration into the Health Care System: Three Perspectives in an Evolving Environment
Session Chair(s)
Michael A Cronin, PharmD
Associate Director, Global Regulatory Lead
Shire, United States
How do we optimize risk evaluation and mitigation strategies (REMS) to improve drug safety in the evolving health care environment? Speakers from FDA, health care, and industry will provide their perspective on REMS integration efforts and discuss how to further advance the standard of pharmaceutical risk management in the US.
Learning Objective : Summarize the progress of FDA’s REMS Integration Initiative; Discuss continued challenges facing the establishment of an effective risk management system using REMS; Identify ways to better incorporate REMS into the broader efforts by stakeholders across the health care spectrum to mitigate pharmaceutical risk.
Speaker(s)
Standardizing and Evaluating REMS: An FDA Update
Theresa A. Toigo, MBA, RPh
FDA, United States
Associate Director for Drug Safety Operations, OCD, CDER
Challenges of Implementing and Evaluating REMS
Paul J. Seligman, MD, MPH
Amgen Inc., United States
Executive Director, Global Regulatory and R&D Policy
Navigating REMS In An Academic Medical Center
Katie Stabi, PharmD
University of Chicago Medicine, United States
Clinical Coordinator, Drug Use Policy and Compliance, Dept of Pharmacy Services
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