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PRIM&R Webinar

IRBs and Expanded Access: Ethical Considerations and Implementing FDA Guidance

Purchase Recording
Watch 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?

Cost

Members: $100 Nonmembers: $190

What Will I Learn?

  • 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.

Audience

  • Ideal for IRB members, staff, and researchers.
  • Recommended Pre-reading:
  • Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products | FDA
  • Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers (fda.gov)

Credits Offered

CE Credit
Participants will receive a certificate of attendance that documents up to 1.5 continuing education credit hours for their attendance at this webinar. Certificates of attendance are useful for obtaining CE credits from professional associations. Each association's guidelines for accepting CE credit hours (in-person or virtual) may differ. Please consult the appropriate association representative for information on if, and how many, CE credits from this PRIM&R webinar may be used.
CIP Credit
Course participants who hold the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP® recertification credit for this PRIM&R webinar. Please refer to the CIP® recertification guidelines for additional information.
Holly Fernandez Lynch, JD, MBE
Assistant Professor of Medical Ethics and Law at the University of Pennsylvania
Megan Kasimatis Singleton, JD, MBE, CIP
Associate Dean for Human Research Protection and Director of the HRPP at Johns Hopkins University School of Medicine
Christine McCracken
Head of Patient Strategies & Solutions (PSS) for the Janssen Pharmaceutical Companies of Johnson & Johnson
Ann Meeker-O’Connell
Director of FDA’s Office of Clinical Policy (OCLiP) in the Office of the Commissioner