[WEBINAR] Lunch Briefing: Understanding and Maximizing the Califf FDA

March 16, 2016

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Watch the Recorded Webinar: Understanding and Maximizing Interactions with the Califf FDA

Dr. Robert Califf’s confirmation as FDA Commissioner will shape the future of American healthcare. So what should the biopharma industry expect and how can companies prepare?

YourEncore policy experts Peter J. Pitts, former FDA Associate Commissioner, and Dr. Tim Franson, immediate Past President of USP, will outline likely key areas of focus for the Califf administration and their impact on your business planning.

Topics covered:

  • Innovation and review strategies
  • Post marketing safety
  • Quality
  • Intra-agency partnerships

Should you brace for impact or embrace for impact? Our experts will help you answer that question.

 Presenters: 

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

Dr. Tim Franson – Chief Medical Officer for YourEncore, Board Member for the Critical Path Institute, and Immediate Past President of the USP Convention. Dr. Franson was also a key contributor to PDUFA V and co-authored the first-ever patient advocacy-initiated guidance for a rare disease submitted to FDA in 2014.

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