NEW YORK, Jan. 30, 2020 (GLOBE NEWSWIRE) — Last week Questex’s 12th Risk Evaluation and Mitigation Strategies (REMS) Summit provided a platform for over 100 attendees to share best practices over the course of two days on how to design, develop, implement and evaluate REMS. The event took place January 21-22 at the Key Bridge Marriott in Arlington, VA.
Regulatory leaders from the FDA, Pfizer, UBC, NOVARTIS, REGENERON, CELGENE, and other life science and regulatory organizations addressed major challenges and had a chance to network, discuss, and learn:
- How E-prescribing can cause a REMS issue and how to mitigate this issue
- The FDA’s new benefit/risk counseling guidelines and how it affects REMS
- Developing application of REMS technology for ease of access
- FDA’s part in reducing the burden of REMS and developing evaluation methods
And so much more.
This year’s Summit featured 18 speakers, including Gita Toyserkani, Regulatory Health Policy Analyst, and Linda Huynh, ORISE Fellow, both from the FDA who presented, A Standardized Approach to REMS Using Implementation Science and How an evidence-based practice (EBP) can be advantageous to promote the use of an effective REMS program that is best modeled for your product and walked the audience through the ways to apply best practices to streamline REMS approval.
Marc Morris, Vice President, Safety and Pharmacovigilance from Apellis Pharmaceuticals discussed Planning for a First REMS in a Clinical-Stage Medium-Size Enterprise and How a lack of Established Policies and Procedures Can Greatly Reduce the Effectiveness of a REMS Program.
Click here for a full list of the 12th REMS Summit speakers.
“UBC was pleased to be a corporate sponsor and co-chair of the 12th REMS Summit in Arlington, VA. Each year, this conference is a mainstay where REMS experts from industry, academia and the FDA gather to share insights and discuss solutions for ensuring patient safety and maintaining the benefit/risk profile of biopharmaceutical products. There are always new and provocative topics presented, as well as updates on technology and strategies for REMS evaluation. We look forward to participating in the 13th Summit in 2021,” said Annette Stemhagen, DrPH, FISPE, Senior Vice President, Chief Science Officer, Safety, Epidemiology, Registries & Risk Management, UBC.
“Excellent event. Relevant and valuable discussions, and a great opportunity to connect with many REMS leaders,” added Kal Elhoregy, Director, Risk Evaluation and Mitigation Strategy (REMS) Programs, Regulatory Affairs Clinical, Amneal Pharmaceuticals.
“At this year’s REMS Summit our attendees learned the necessary elements that need to be included in REMS for their product, as well as details required for submission. Our adept speaking faculty armed delegates with proven strategies to facilitate benefit-risk counseling, optimize REMS operations through streamlined health system integration, leverage interoperable technologies for consistent communication, and increase patient safety through cross-functional collaboration,” said Greg Khemai, Senior Conference Director, ExL Events, a division of Questex.
To learn more about the 12th Risk Evaluation and Mitigation Strategies (REMS) Summit, click here.
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