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

December 3, 2015 Tim Franson, MD



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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