22 - 24 October, 2019 | Mercure Hotel MOA Berlin, Berlin, Germany
John Weiner, Associate Director FDA Office of Combination Products at FDA
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John Weiner


Associate Director FDA Office of Combination Products
FDA

Check out the incredible speaker line-up to see who will be joining John.

Download The Latest Agenda

Main Conference Day One

Wednesday, October 23rd, 2019


9:10 AM The FDA Regulatory Landscape

  • Discuss the regulation of other combined uses of medical products in the US
  • Address policy developments from pre-market through post market, including topics on pathway availability, key review issues such as bridging and human factors, CGMPs and post market safety reporting
  • Consider regulatory issues relating to combined use products more broadly, including software and technology enabled devices  intended to enable and enhance safe and effective prevention, diagnosis and treatment