Regulatory Convergence & Divergence:  3 Possible Monkey Wrenches in Pharmaceutical Development Planning

December 3, 2015 Tim Franson, MD

 

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While there has been much progress to harmonize EMA and FDA regulations for drug development, there are still areas where the respective agencies differ.  And these differences can have a direct impact on pharmaceutical development planning.

To shed some light on the topic, on October 26th YourEncore assembled an all-star panel of industry experts after RAPS Convergence to share their inside perspectives on three particular areas of divergence/convergence:

  • Biomarkers: Qualification and integration in individual development programs
  • EU/US PIP (Pediatric Implementation Plans)
  • Drug Safety: EU’s interest in non-serious events and FDA’s post approval risk versus benefit-risk focus

We filmed the session, so all could hear from our distinguished panel, which I was fortunate to moderate. Access the video by clicking the banner below. 

The participants included:

Martha Brumfield, Ph.D. - President and Chief Executive Officer of the Critical Path Institute and the incoming President of the Board of Directors for the Regulatory Affairs Professional Society (RAPS).

Peter J. Pitts - YourEncore executive partner, former FDA Associate Commissioner, current Chief Regulatory Officer for Adherent Health Strategies and Founder/President of the Center for Medicine in the Public Interest.

Stephen Spielberg, M.D., Ph.D - YourEncore senior advisor, former FDA Deputy Commissioner for Medical Products & Tobacco, Dean of Dartmouth Medical School and Editor-in-Chief of the Drug Information Association’s (DIA) journal, Therapeutic Innovation and Regulatory Science

Don Therasse, M.D. - YourEncore executive partner, former VP, Global Patient Safety and Global Medical Affairs at Lilly, he led Lilly’s pharmacovigilance organization and established Lilly’s global medical affairs, benefit-risk assessment and bioethics organizations

I hope you enjoy watching or listening to the session and stay tuned for future events.

Watch the Regulatory Convergence & Divergence Expert Panel Discussion

 

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