Free Webinar: Reviewing Research Involving Medical Devices

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Reviewing research involving medical devices is challenging – ethical principles, regulatory requirements, and device documentation issues abound. This presentation breaks down the complexities to provide an understanding of medical devices as used in clinical trials. This free 1 Hour Webinar was presented by Quorum Review’s regulatory expert, Mitchell Parrish, JD, RAC, CIP, and provided an informative perspective on this important industry topic.

This webinar qualified for 1 hour of CIP CE or 1 point toward ACRP self-reported credit.

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TUESDAY, September 23rd Session
10:00 AM Pacific | 12:00 PM Central
1:00 PM Eastern
THURSDAY, September 25rd Session
10:00 AM Pacific | 12:00 PM Central
1:00 PM Eastern

What we cover:

  • Regulations governing medical device research in the U.S. and Canada
  • Terms such as Class 1, 510(k), PMA, IDE, NSR, Exempt, Licensed, and ITA
  • Special considerations for combination products, humanitarian use devices, in vitro diagnostics, and adaptive clinical trials

The webinar was broadcasted twice: September 23 (TUES) and September 25 (THURS) from 10:00am to 11:00am Pacific Time (1:00pm Eastern, 12:00pm Central, and 11:00am Mountain).

Who should attend:

  • Research professionals
  • Sponsors and CROs
  • Research Sites
  • Anyone interested medical device review as it pertains to the IRB perspective

Continuing Education Credit: By attending this webinar, you will be eligible for 1 hour (or 1 point) of CIP CE or ACRP credit. Both sessions (Tuesday and Thursday) cover the same material, so only 1 hour will be credited to you regardless of whether you attend both sessions. Certificates of Attendance will only be dispatched to the email addresses that are used to sign up for and attend the webinar. We are unable to provide certificates to anyone whose email address is not on the sign-up list or who does not attend during the announced times.


 Speaker Biography

Mitchell Parrish, JD, RAC, CIP
Quorum Review Regulatory Attorney

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Mr. Parrish is a Regulatory Attorney for Quorum Review, where he provides legal counsel on regulatory issues and FDA requirements associated with research and development of medical products. Mr. Parrish is a member of the Regulatory Affairs Professionals Society, Public Responsibility in Medicine & Research, Association of Corporate Counsel, and Washington State Bar Association. He is also a Certified IRB Professional (CIP) and guest lectures for the Masters of Science Program in Biomedical Regulatory Affairs at the University of Washington.

 

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