ParagonRx® | Minimize Risk and Optimize Use

Wednesday FoREMS discussion

February 10, 2010 at 12:00 PM Eastern Time

Beginning with the End in Mind:  Managing the Lifecycle of REMS Implementation

In the midst of the anxiety and uncertainty of developing and negotiating a REMS for FDA approval, members of REMS teams at pharmaceutical companies can sometimes focus on REMS approval as an endpoint.  In reality, it is a beginning of:

• Developing an implementation plan
• Identifying and selecting internal and external resources to implement the REMS
• Coordinating the activities of internal and external resources to execute the implementation plan
• Measuring distribution metrics to determine operational compliance
• Tracking all metrics in an organized (and perhaps automated) way to know the status of REMS compliance at any time

Join us for the next webinar in our Wednesday FoREMS series on February 10th, at 12 noon EST. Jeff Fetterman will be discussing REMS Implementation and best practices to achieve REMS effectiveness. Please send your questions in advance and participate during the discussion as well.

If you have not already registered for Wednesday FoREMS, please register so you can participate.