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

John Weiner

Associate Director FDA Office of Combination Products

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

Download The Latest Agenda

Main Conference Day Two

Thursday, October 24th, 2019

2:40 PM 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