Webinar: IRBs and Expanded Access: Ethical Considerations and Implementing FDA Guidance

When:  Aug 13, 2024 from 01:00 PM to 02:30 PM (ET)

Join this panel discussion to gain an understanding of expanded access (sometimes called “compassionate use”), the ethical issues involved, and an overview of recent regulatory and policy developments. With a panel of individuals including representatives from the FDA, industry, and academia, this educational opportunity will discuss the FDA’s new guidance on IRB Review of Individual Patient Expanded Access Submissions and provide considerations for implementation.

What practical considerations are IRBs and HRPPs making for expedited review? How should oversight bodies be thinking about data collection from expanded access patients? What are the FDA expectations? Who are the stakeholders involved in this process and how can they most effectively engage?

After this webinar, you will be able to: 

  • Define expanded access and identify relevant stakeholders.
  • Understand the key components of the new FDA Guidance related to IRB review of Individual Patient Expanded Access Requests.
  • Examine different perspectives about implementation of the guidance to help inform practice.