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AN INTRODUCTION TO THE U.S. FDA’S INVESTIGATIONAL DEVICE EXEMPTION (IDE): A GCMI WEBINAR
April 14, 2022 @ 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
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