Ask the Expert On Demand Webinar: Do We Need REMS?

Risk Evaluation and Mitigation Strategies (REMS) are regulatory risk management programs that can be used to ensure that drug benefit outweighs risk. Because REMS can include requirements that may impose burden on patients and/or prescribers or restrict drug access, their net benefit has been debated. Using case studies of anticonvulsant safety, this webinar will review the regulatory framework and the scientific evidence surrounding REMS programs

At the end of this webinar, attendees should be able to:

Describe the regulatory framework surrounding REMS programs
Explain decision making that determines implementation and discontinuation of REMS programs
Describe evidence assessing the need for REMS and REMS effectiveness

Almut G Winterstein, RPh, PhD, FISPE
Speaker
Almut Winterstein is Distinguished Professor and the Dr. Robert and Barbara Crisafi Chair for Medication Safety in the Department of Pharmaceutical Outcomes and Policy and the Department of Epidemiology, and the founding Director of the Center for Drug Evaluation and Safety at the University of Florida. Since 2019, she also serves as director of the Consortium for Medical Marijuana Clinical Outcomes Research, a state-funded consortium of 11 universities in Florida. Dr. Winterstein’s research interests center on the post-marketing evaluation of medications in pediatrics and pregnancy, infectious disease and psychiatry and the evaluation of policy surrounding medication use using real-world data. As expert in drug safety, she has chaired the Food and Drug Administration’s Drug Safety and Risk Management Advisory Committee from 2012-2018. Recognizing her contributions in pharmacoepidemiology, Dr. Winterstein was inducted as a fellow of the International Society of Pharmacoepidemiology in 2013 and served as president of the society from 2019-2020. In 2022, she was inducted in the Academy of Science, Engineering and Medicine in Florida. She received her pharmacy degree from Friedrich Wilhelm University in Bonn, Germany and her PhD in Pharmacoepidemiology from Humboldt University in Berlin.

VibhanginiS. Wasade, MD, FAES
Moderator
Dr. Wasade is a board-certified neurologist and epileptologist at Henry Ford Hospital, MI and currently also serves as a Clinical Associate Professor at Michigan State University and Wayne State University, MI. Dr. Wasade holds several leadership roles at Henry Ford Hospital, including the Epilepsy Division Chief, and Medical Director of the Comprehensive Epilepsy Program and Director of the Epilepsy Monitoring Unit. She has also served as Associate Program Director for the Clinical Neurophysiology Fellowship (EEG track) and has been actively involved in medical education and training the next generation of neurologists. Her academic work includes contributions to epilepsy literature, with numerous peer-reviewed publications, book chapters, and presentations focusing on epilepsy, clinical outcomes, and advanced treatment approaches for epilepsy.

Disclosure Policy
It is the policy of the American Epilepsy Society (AES) to ensure balance, independence, objectivity and scientific rigor. All individuals involved in the selection, development and presentation of content are required to disclose any real or apparent conflicts of interest. Conflicts of interest will be resolved by AES prior to an educational activity being delivered to learners.

Planning Committee, Faculty, Reviewers' Disclosures of Financial Relationships
In accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education, the AES requires that any person who is in a position to control content of a CME activity must disclose all relevant financial relationships that they have with an ineligible company. Unless otherwise indicated (*), none of the planners or faculty of this activity have any financial relationships to disclose. All relevant financial relationships with ineligible companies have been mitigated. The following individuals contributed to this activity's content. Update for all courses this year.

Planning Committee and Faculty
Wolfgang Muhlohofer, MD (Chair)
Jaysingh Singh, MD (Vice Chair)
Ruba Al-Ramadhani, MD
Evelyn Berman, MD
Jonathan Dashkoff, MD
Proleta Datta, MD
Alyssa Ho, MD
Matthew Hoerth, MD
Scheherazade Le, MD
Jose Montes-Rivera, MD
Georgios Ntolkeras, MD
Rebecca O'Dwyer, MD
Viktoras Palys, MD
Christopher Ryan
Priyanka Sabharwal, MD
Yash Shah
Aparna Vaddiparti
Lawrence Ver Hoef
Kristine Ziemba, MD

CME Reviewer
Simona Proteasa, MD

American Epilepsy Society Staff Planners
Melissa Ball, CAE, PMP

Resolution of Conflicts of Interest
It is the policy of the American Epilepsy Society to ensure balance, independence, objectivity and scientific rigor. All persons involved in the selection, development and presentation of content are required to disclose any real or apparent conflicts of interest. In accordance with the ACCME Standards for Commercial Support of CME, the AES implemented the mechanisms of prospective peer review of this CME activity, to identify and resolve any conflicts. Additionally, the content of this activity is based on the best available evidence.

Accreditation
The American Epilepsy Society is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

For more information regarding contact hours, please call American Epilepsy Society 312.883.3800 or education@aesnet.org.

Credit Designation
The American Epilepsy Society designates this enduring activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CME Certificate
To receive credit for your participation in this activity, please complete the evaluation survey provided at the conclusion of the activity.

Unapproved Use Disclosure
The American Epilepsy Society requires CME authors to disclose to learners when products or procedures being discussed are off-label, unlabeled, experimental, and/or investigational (not FDA approved); and any limitations on the information that is presented, such as data that are preliminary or that represent ongoing research, interim analyses, and/or unsupported opinion. This information is intended solely for continuing medical education and is not intended to promote off-label use of these medications. If you have questions, contact the medical affairs department of the manufacturer for the most recent prescribing information. Information about pharmaceutical agents/devices that is outside of U.S. Food and Drug Administration approved labeling may be contained in this activity.

Disclaimer
This CME activity is for educational purposes only and does not constitute the opinion or endorsement of, or promotion by, the American Epilepsy Society. Reasonable efforts have been taken to present educational subject matter in a balanced, unbiased fashion, and in compliance with regulatory requirements. However, each activity participant must always use his or her own personal and professional judgment when considering further application of this information, particularly as it may relate to patient diagnostic or treatment decisions including, without limitation, FDA-approved uses and any off-label, investigational and/or experimental uses.