Presented by Mitchell Parrish, JD, RAC, CIP, this webinar discussed:
- 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
About the Speaker
Mitchell Parrish, is the Vice President of Legal Affairs and General Counsel for Kinetiq, a consulting and technology division of Quorum Review IRB. Mitchell has served in-house and outside counsel roles as a consultant to the National Cancer Institute, as a regulatory counsel to a large central IRB, and as an associate attorney at the global law firm K&L Gates. He is a frequent speaker and published author on clinical trials topics. He is a member of the Washington and Oregon State bars and Regulatory Affairs Professionals Society; is a Certified IRB Professional (CIP); and has his Regulatory Affairs Certification (RAC).
This webinar is eligible for continuing education credits.
Continuing Education Credits
This webinar is pre-approved for 1.0 contact hours of continuing education credit for the Certified IRB Professional (CIP) certification, and for Maintenance of ACRP’s CCRC®, CCRA®, CCTI® or CPI® certifications. If you would like to obtain CE credits for a different credential, please check with your professional organization to determine if our webinars meet their continuing education requirements. Information for CE credits for SOCRA can be found here. Visit our Webinars Help page for more information on certification credits.
Certificate of Attendance
You must watch this webinar in its entirety to receive a certificate of attendance. The certificate will include your full name and it will be emailed to you at the end of the webinar. Please note that if your organization has other staff members who wish to earn CE credits for this webinar, each person must register for and watch the webinar in its entirety in order to receive a certificate. Visit our Webinars Help page for more information on certificates of attendance.
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Tags: 510(k), adaptive trials, combination products, FDA, Health Canada, Humanitarian Use Devices, IDE, in vitro diagnostics, IRB webinar, medical device research, medical devices, Quorum Review IRB, TCPS