A complimentary webinar will be presented by ParagonRx on the implications and ramifications of the newly released FDA draft guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS).
“Our ‘Guidance’ on the FDA Draft Guidance for MedGuides in REMS” will be the focus of a free webinar which will take place Wednesday, March 9, at 12 noon Eastern Time. The topic is the latest in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx, an inVentiv Health company, pioneering expertise in REMS and Benefit-Risk Management.
“In addition to other topics, this guidance addresses when a Medication Guide will be required as part of a REMS,” says ParagonRx President, Jeffrey Fetterman. “Given that 67% of all REMS programs include only MedGuides and assessments as the program elements, the implications of this guidance are essential knowledge for industry professionals.”
Topics to be covered include:
- Review provisions of draft guidance
- Implications and commentary
- Recommendations
In addition to Fetterman, ParagonRx executives William “Billy” Holden, PhD, Chief Safety Officer, and Karen Lenoir, Client Services Director, will participate in the webinar.
More information about registering for the “Wednesday FoREMS” webinar series can be found at www.paragonrx.com/rems-hub/forems/. Webinars are held the second Wednesday of each month at 12 noon EST.