Of the 146 FDA REMS programs approved to date, 41 of them – almost one-third – have already been modified. Undoubtedly, REMS assessment findings have played a role. In addition, new insights arising from FDA comments influence the design of future assessments. These topics will be the focus of a free webinar hosted by ParagonRx which will take place this Wednesday, October 13, at 12 noon Eastern Time.
Entitled “Hot Topics in REMS Assessments,” it is the latest in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx, an inVentiv Health company, and a leading consulting company specializing in pharmaceutical risk management and optimizing medication.
“ParagonRx has worked with many pharma and biotech companies on their REMS assessments,” says ParagonRx CEO Jeffrey Fetterman, “and there is much to be learned about FDA’s evolving standards as they are reflected in their communications to sponsors.”
Karen Lenoir, Client Services Director of ParagonRx, and Larry Risen, President of BioTrak Research, will lead the participants through such topics as appropriate sample size for surveys, the regulatory compliance basis of REMS assessments, the influence of Medication Guide changes, performance benchmarks and corrective actions based upon assessment results. There will also be a Q&A session with the experts following the presentation.
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 EST.