Watch On-Demand
About the Webinar
This webinar is aimed at all stakeholders in clinical research, including sponsors, CROs, institutions, and sites. Our experts dive into the intricacies of the FDA’s proposed single Institutional Review Board (sIRB) Mandate, providing crucial insights and updates to ensure your organization remains compliant and efficient in multi-site clinical trials.
Topics covered include:
- Recap of the 2023 NPRMs: We start by revisiting the key points of the 2023 Notice of Proposed Rulemaking (NPRM), highlighting the proposed changes and their potential impact on clinical research stakeholders.
- Update on Changes: Get up-to-date with the latest developments surrounding the FDA’s proposed Single IRB Mandate. We explore what has changed since the NPRM and discuss how these changes may affect your organization’s operations and procedures.
- Demystifying the FDA: Ever wonder why FDA mandates seem to take forever to become final rules? We demystify this process, providing clarity on the intricacies and timelines involved in regulatory decision-making at the FDA.
Plus, our experts discuss why aligning to the sIRB mandate sooner rather than later is advantageous to accelerating your research. Don’t miss this opportunity to gain valuable insights and strategies for navigating the FDA’s proposed Single IRB Mandate. Register now to secure your spot and stay ahead in the ever-evolving landscape of clinical research compliance.