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

• Presenters
• CE Credits
• Certificate of Attendance

Sara Raboin

PhD

Director of Operations
Yale Cancer Center

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.

We are pleased to support the clinical research community with educational content. As of September 2025, we are making updates to improve both our educational programs and the process for providing certificates of participation. While these changes are underway, our automated certificate system is temporarily unavailable.

Certificates of participation may be requested by emailing webinar@advarra.com. We appreciate your patience during this transition and encourage you to check back for updates, as we look forward to offering an improved experience in the future.