Demystifying North American IRB/EC Requirements for International Research Professionals

Managing ethics committee reviews for sites in North America is typically quite straightforward, even if you’re managing the submission from outside the region.

In fact, there are some differences in U.S. and Canadian regulations designed to make ethics committee oversight a lot easier to obtain than in some parts of the world.

Once you know the basics, you can streamline study startup and gain more visibility and control in the ethics review process.

Watch this webinar to learn how the U.S. FDA and Health Canada regulations apply, what to expect during the review process, and best practices to set up your submission for success – including specific examples from Noema, a clinical-stage biotech sponsor based in Switzerland.

Learning Objectives:

• Summarize U.S. FDA and Health Canada requirements for research ethics review and the IRB/REB review fundamentals in North America
• Demonstrate how one sponsor streamlined ethics review using best practices
• Understand where to access additional information and support from regulatory resources

• Presenter
• CE Credits
• Certificate of Attendance

James Riddle

MCSE, CIP, CPIA, CRQM

Senior Vice President, Global Review Operations

Denise Bedoya

Director, Clinical Operations, Noema Pharma

Lindsay Lickers

Clinical Trial Associate, Noema Pharma

The Society of Clinical Research Associates (SOCRA – www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 1 hour of CE credit.

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.

After watching this webinar in its entirety and completing the webinar survey, you will receive a certificate of attendance. This certificate will be emailed to you within one business day of watching the webinar. Please note that if your organization has other staff members who wish to get a certificate of attendance, each person must register, watch the webinar in its entirety, and complete the webinar survey. Visit our Webinar Help page for more information on certificates of attendance.