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Incorporating continuing education into single-drug REMS: Exploring the challenges and opportunities

The Risk Evaluation and Mitigation Strategies (REMS) program has become an important tool of the U.S. Food and Drug Administration (FDA) in ensuring that the benefits of a given medical product outweigh the associated risks, and has enabled FDA to approve a number of products that might not otherwise have been made available for patient use. Since the implementation of the REMS program, however, concerns have been raised regarding its impact on patient access to products and the associated burden on providers and health care systems. In an effort to address these concerns—and as part of its commitments under the Prescription Drug User Fee Act reauthorization of 2012—FDA has undertaken efforts to standardize and improve the effectiveness of REMS, and to better integrate REMS programs into the health system. As part of this broader initiative, the Agency is currently assessing the feasibility of integrating accredited continuing education (CE) programs and activities into REMS programs that have been developed for a single drug.

Under a cooperative agreement with the FDA, the Center for Health Policy held an expert workshop on May 18, titled “Incorporating Continuing Education into Single-Drug REMS: Exploring the Challenges and Opportunities”. This workshop provided an opportunity for pharmaceutical manufacturers, regulators, CE providers, accreditors, and other stakeholders to explore the ways that CE can be a valuable addition to the REMS toolkit, discuss potential barriers to the development and implementation of REMS-related CE for single products, and identify strategies for addressing those barriers.


Welcome, overview, and meeting objectives

Incorporating continuing education into REMS


Claudia Manzo

Director, Office of Medication Error Prevention and Risk Management - U.S. Food and Drug Administration

Lessons from the ER/LA opioid REMS development process


Linda Kitlinski

REMS Education Consultant and Retired Co-Chair of RPC CE Sub-team


Kate Regnier

Executive Vice President - Accreditation Council for Continuing Medical Education


Terry Toigo

Associate Director of Drug Safety Operations, Office of the Center Director - U.S. Food and Drug Administration

Session I: Defining the critical elements that are essential for CE as part of a REMS


Maureen Cahill

Associate, Nursing Regulation - National Council of State Boards of Nursing


Kathy Chappell

Vice President, Accreditation Program and Institute for Credentialing Research - American Nurses Credentialing Center


Anne Grupe

Director, Continuing Medical Education - American Society of Clinical Oncology


Julie Webb

Vice President, Office of Professional Development - American Society of Health-System Pharmacists

Session II: CE programs for single drug REMS: Developing valid and high-impact content


Gary Appio

Head, US Safety Risk Management, Global Drug Safety & Epidemiology - Novartis Pharmaceuticals Corporation


Eric Peterson

Senior Director, Performance Improvement CME - American Academy of Physician Assistants


Peter Vlasses

Executive Director - Accreditation Council for Pharmacy Education


Julie White

Director, The Barry M. Manuel Office of Continuing Medical Education - Boston University School of Medicine

Session III: CE programs for single drug REMS: Best-practices for implementation and uptake


Paul Coplan

Executive Director, Risk Management and Epidemiology - Purdue Pharmaceuticals


Cyndi Grimes

Director, Continuing Medical Education - Medscape


Ann Karty

Medical Director, Continuing Education - American Academy of Family Physicians

Session IV: Identifying other key facilitators and barriers to REMS CE development and uptake

Session V: Major takeaways and next steps

Closing remarks

More Information


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