Are the risk mitigation measures within a REMS (Risk Evaluation and Mitigation Strategy) adequate enough to ensure optimal benefit-risk management? Even if the FDA doesn’t require a REMS for a product, does it make sense to undertake risk management measures anyway?
These are the questions that will be addressed in a free webinar, “Voluntary Risk Management Measures: Opportunity or Overkill?” which will take place this Wednesday, April 13, at 12 noon Eastern Time. The topic is the latest in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx.
“The FDA’s draft guidance for REMS specifies that applicants may undertake voluntary risk management measures that are performed outside of a REMS,” points out ParagonRx President Jeffrey Fetterman, who will lead the webinar. “Some risk management professionals have successfully used such measures to achieve benefit-risk management objectives, while others wonder if it could be overkill that diverts resources and attention.”
The webinar describes four specific roles for voluntary risk management measures, explores how such measures can be effectively designed, and looks at case studies of successful use.
More information about registering for the “Wednesday FoREMS” webinar series can be found at www.paragonrx.com/rems-hub/forems/. Webinars will be held the second Wednesday of each month at 12 noon EDT.