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Ask the Experts: Rapid Design & Development in Highly Regulated Environment

Eri Hirumi  (Regulatory Affairs Specialist, Microvention)

Laura Jeannel  (Senior Technical Specialist, Meridian BioGroup)

Location: Biomed Room 1

Date: Thursday, September 17

Time: 9:30am - 10:15am

Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs

Vault Recording: TBD

The current industry landscape for innovative medical devices has become more competitive and challenging in recent years, with the ever-impending regulatory hurdles to jump through. Proper collaboration between companies and regulatory bodies is more crucial for development than ever before. During this interactive session, two experts will go into a short discussion on how to bridge the gap between innovator and regulator, and then open the floor to the audience for an extended Q&A session. In this format, the experts will encourage comments, insights or questions from attendees to engage in a collaborative discussion. Join this gathering to hear from your peers, learn from experts, and accelerate the rate at which your innovations are available to the public.

Topics include:
  • How the rate of approval by FDA of medical devices has changed in an era of Covid-19 with the EUA designation
  • Steps for developing innovative and efficient regulatory strategies and plans
  • A timeline and checklist for developing your strategy