The Association of Clinical Research Professionals

Webinar Replay: Best of ACRP 2019 – EFS is the new OUS strategy for early-phased medical device clinical trials

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires December 12, 2022.


Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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Webinar Replay December 12, 2022.


Speakers:

  • Chris Cain, RN, MBA, CCRA, RAC – VP, Clinical & Regulatory Affairs, Conformal Medical, Inc.
  • Victor Chen – Managing Director, Clinical Trials, Kaiser Permanente

This session will provide the participant with several real-world examples of the benefits and risks of conducting early-phased medical device clinical trials, and the strategies involved in optimizing this avenue for regulatory submissions. The participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.

Upon completion of this Webinar, attendees should be able to:

  1. Define FDA’s Early Feasibility Study (EFS) Program
  2. Outline the risks/benefits of participating in the EFS program for early-phased clinical trials
  3. Outline strategies to leverage EFS protocols for PMA and 510 submissions