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Wednesday, June 26 • 2:00pm - 3:15pm
#355: History of Risk Evaluation and Mitigation Strategies (REMS): What Have We Learned?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-683-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks when used in real-world settings. Today, there are approximately 75 active REMS programs. This forum will discuss the evolution of risk management in the U.S. culminating with the inception and implementation of REMS. Presentations by speakers from FDA, industry, and academia will discuss FDA Guidance to Industry; how REMS are being operationalized and integrated into the healthcare system; FDA’s framework for benefit-risk counseling to patients about drug’s with a REMS; and pragmatic approaches from implementation science for informing REMS design and assessment. Interactive audience engagement will occur throughout the forum to stimulate dialogue on implications for advancing risk management science and practice. Discussion questions will include: What areas for further risk management guidance development are you most interested in? and why? What opportunities do you see for further integrating REMS into the healthcare system? What challenges, or barriers, have you experienced when implementing patient-counseling frameworks? How have you overcome them? What ideas do you have for further advancing the science of REMS?

Learning Objectives

Describe the evolution of FDA risk management guidance and implementation of REMS over the past decade; Discuss challenges and solutions for operationalizing risk management frameworks and guidance and integrating REMS into the healthcare system; Identify pragmatic scientific approaches for ensuring pre- and post-market continuity in safety management planning and execution.


Elaine Morrato, DrPH, MPH


Evolution of Risk Management and FDA’s Regulatory Guidance
Cynthia LaCivita, PharmD

Opportunities for Integrating REMS into the Healthcare System
Gita Toyserkani, PharmD, MBA

The FDA’s New Benefit-Risk Counseling Framework: How Do Manufacturers Operationalize It?
Hilda Wiryawan Chan, MD, PhD, MPH

Application of Implementation Science for REMS Design and Assessment
Elaine Morrato, DrPH, MPH

avatar for Hilda Chan

Hilda Chan

Benefit Risk Management Scientist, Amgen
Hilda Chan, MD, MPH, PhD is a Benefit-Risk Management Scientist in the Global Patient Safety, Labeling, and Pediatrics department at Amgen Inc. Her primary responsibilities include leading teams in conducting structured benefit-risk assessments for products in the therapeutic areas... Read More →
avatar for Cynthia LaCivita

Cynthia LaCivita

Director, Division of Risk Management, OMEPRM, OSE, CDER, FDA, United States
Cynthia LaCivita earned her undergraduate degree in microbiology and Doctor of Pharmacy from the University of Maryland (U of MD) and completed an oncology residency at the University of Maryland Cancer Center (UMCC). She was an assistant professor in the Department of Pharmacy Practice... Read More →
avatar for Elaine Morrato

Elaine Morrato

Professor Health Systems, Management and Policy, Colorado School of Public Health
Elaine Morrato, DrPH MPH is a Professor in Health Systems, Management and Policy and Associate Dean for Public Health Practice at the Colorado School of Public Health. Her research focuses on accelerating the translation of drug warnings into practice, and she has contributed her... Read More →
avatar for Gita Toyserkani

Gita Toyserkani

Associate Director, Research & Strategic Initiatives, FDA
Gita A. Toyserkani, PharmD, MBA, is the Associate Director for Research and Strategic Initiatives in the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology. She has over 15 years of experience in drug safety and advises on pre and post-marketing activities... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Forum