Leadership challenges and best practices in dealing with FDA’s REMS

Three pharmaceutical executives with extensive experience in dealing with the FDA’s Risk Evaluation and Mitigation Strategy (REMS) will share their thoughts and practices at an open industry webinar at 12 noon EST on Wednesday, March 10, sponsored by ParagonRx.

Entitled “REMS Leadership Challenges and Best Practices,” it is the fourth in a series of monthly “Wednesday FoREMS” webinars sponsored by ParagonRx, an inVentiv Health, Inc. company (Nasdaq: VTIV) and a leading consulting company specializing in pharmaceutical risk management and optimizing medication.

The speakers will be Heather Schiappacasse (Director, sanofi-aventis), Arthur Morelli (Vice President Medical Affairs Operations, Covidien) and Daniel Reshef (Director, Hoffmann-La Roche Inc.). They will address, respectively, leading the REMS process internally and externally, leading organizational change and program management, and leading REMS generic implementation. The presentations will last 30 minutes, followed by 30 minutes of Q&A from webinar participants and discussion by the panelists.

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.