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Wednesday, June 27 • 10:30am - 11:45am
#329: Reducing the Burden of Drug Safety Risk Minimization Programs on the Healthcare System: How Do We Do So and What Has Been Learned to Date?

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-638-L04-P; CME 1.25; IACET 1.25; RN 1.25

As part of its REMS integration initiative under the Prescription Drug User Fee Act V, the FDA committed to improving the integration of risk evaluation and mitigation strategies (REMS) into the healthcare system. A designated team (the Design and Standardization Work Group) was established to identify best practices to incorporate into REMS design, as well as appropriate ways to standardize REMS tools and integrate REMS into the healthcare delivery system. Results of this workstream have important implications for how industry designs its REMS programs moving forward as well as for the efficiency of the healthcare system.
This session will discuss how it remains unclear as to how to accomplish this goal from a practical perspective.

Learning Objectives

Describe the nature of FDA’s commitment to reduce the burden of REMS on the healthcare system and to provide an update on the design and standardization workstream; Discuss a REMS program that was successfully integrated into the clinical workflow; Identify policy options for integrating REMS into the healthcare system.


Meredith Y. Smith


An Update on the FDA's Design and Standardization Workstream in Regard to Integrating REMS Into the Health Care System
Gerald J. Dal Pan, MD, MHS

Factors Impacting Selection of Risk Minimization Interventions
Sarah A. Frise

What are the Policy Options for Facilitating the Integration of REMS Strategies into the Healthcare System?
Gregory Daniel, PhD, MPH, RPh

avatar for Gregory Daniel

Gregory Daniel

Deputy Director and Clinical Professor, Duke-Margolis Center For Health Policy
Gregory Daniel, PhD, MPH is the Deputy Director of the Duke-Robert J. Margolis, MD Center for Health Policy and a Clinical Professor in Duke's Fuqua School of Business. He directs the DC-based office of the Center leading its pharmaceutical and medical device policy portfolio, and... Read More →
avatar for Sarah Frise

Sarah Frise

Global Director Risk Management, AstraZeneca
Sarah holds a Masters Degree in Physiology and Phd in Epidemiology. Sarah holds the position of the Global Director, Risk Management at AstraZeneca and a faculty position in Epidemiology at the University of Toronto. She is an active member of many Pharmacovigilance working groups... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the... Read More →
avatar for Meredith Smith

Meredith Smith

Global Risk Management Officer, Global Patient Safety, Amgen Inc.
Meredith Smith is Global Risk Management Officer at Amgen, Inc. where she leads a team of 6 scientists responsible for medicinal product benefit-risk assessment and risk management. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →

Wednesday June 27, 2018 10:30am - 11:45am EDT
Room 253AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session