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AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR

April 14 @ 12:30 pm - 1:30 pm

Free

Ted Heise, PhD, RAC, Vice President of Regulatory and Clinical Services, will be a panelist on this upcoming webinar.

What will attendees learn?

  • What’s required by FDA to get into an IDE trial: Hint: robust design history files, and answers to questions that validate or confirm clinical hypotheses.
  • What clinical trials need to answer in order for the greatest potential for regulatory approval. Hint: key players include regulatory associates, internal review boards, contract research associates and design history file team members.
  • Clarity on pathway to regulatory approval in clinical use and broad patient populations.

Who should attend?

  • Early stage medical device and technology companies
  • Academic investigators
  • Physician entrepreneurs
  • Clinicians interested in participating in clinical studies
  • Investors in new medical technologies who want to ensure capital efficient design, development and regulatory approval pathways for their invested companies

Details

Date:
April 14
Time:
12:30 pm - 1:30 pm
Cost:
Free
Website:
https://gcmiatl.com/2022/03/07/webinar-an-intro-to-the-fda-investigational-device-exemption/

Organizer

GCMI

Venue

Live Virtual

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