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.

Join 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

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