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Developing Innovative Regulatory Plans for New Products

Eri Hirumi  (Regulatory Affairs Specialist, Microvention)

Location: 210D

Date: Tuesday, February 11

Time: 4:05pm - 5:00pm

Track: MD&M Conference: Keeping Up & Staying Compliant with Global & FDA Regulations

Vault Recording: TBD

As new and innovative products are developed, new and fast track regulatory plans must be co-developed. Balancing the need to have safe and effective medical devices against the desire for fast and easy access to innovative products is always a challenge. Global regulatory agencies are constantly striving to meet this need. This session will explore the different options and global pathways to market. Your strategy can affect how quickly your product will or won’t get to market.

Topics covered include:

  • Hands-on experience on how to read regulations and understand the requirements
  • Steps for developing innovative and efficient regulatory strategies and plans
  • A timeline and checklist for developing your strategy

Presentation File

ANA2020_DevelopingInnovativeRegulatoryPlans_Hirumi.pdf