YourEncore RAPS Panel - Regulatory Convergence & Divergence
"Regulatory Convergence & Divergence: 3 Possible Monkey Wrenches in Pharmaceutical Development Planning." While there has been much progress to harmonize EMA and FDA regulations for drug development, there are still areas where the respective agencies differ. It is important for regulatory professionals to understand key areas of convergence and divergence, because they can have a direct impact on development planning and safety compliance. YourEncore has assembled an all-star panel of industry experts to share their inside perspectives on three particular areas of divergence/convergence: Drug Safety: EU’s interest in non-serious events and FDA’s post approval risk versus benefit-risk focus Biomarkers: Qualification and integration in individual development programs EU/US PIP (Pediatric Implementation Plan) Panelist Include: Tim Franson, M.D. is the Chief Medical Officer for YourEncore, Board Member for the Critical Path Institute, and immediate Past President of the USP Convention. Martha Brumfield, Ph.D. is President and Chief Executive Officer of the Critical Path Institute, and serves as President of the Board of Directors for the Regulatory Affairs Professional Society (RAPS). Peter J. Pitts is an authority on global regulatory issues. He is a former FDA Associate Commissioner, the Chief Regulatory Officer for Adherent Health Strategies, and the President of the Center for Medicine in the Public Interest, a policy institute he founded in 2004. Stephen Spielberg, M.D., Ph.D is a pediatric drug development experts, with over 40-years experience in pediatrics, clinical pharmacology, drug safety and pharmacogenomics. Dr. Spielberg has served as Dean of Dartmouth Medical School, Vice President for Pediatric Drug Development at Johnson & Johnson, and as Deputy Commissioner for Medical Products at the FDA. Don Therasse, M.D. is a leading expert in medical affairs and drug safety with over two decades of experience in big pharma. Prior to joining YourEncore’s Regulatory Practice, Don served as Eli Lilly and Company Vice President, Global Patient Safety and Bioethics.