Day 3 Session 1 - GCP R3loaded: How ICH E6 R3 is Reshaping the TMF Landscape скачать в хорошем качестве

Day 3 Session 1 - GCP R3loaded: How ICH E6 R3 is Reshaping the TMF Landscape

The newly released ICH E6(R3) guidance brings a major shift to clinical trial operations—and with it, important implications for the TMF. In this session, we’ll break down the new structure of the document, highlight key changes, and focus specifically on updates related to trial records and documentation. Drawing on insights from recent regulator presentations, this session will help you understand how the revised guidance impacts TMF management and what adjustments may be necessary to stay compliant. Whether you're a TMF lead or a clinical operations professional, this is essential knowledge for staying ahead of regulatory expectations. What you'll learn: How the structure of ICH E6(R3) differs from previous versions Major changes and additions relevant to trial documentation Updates to records management that directly impact the TMF Key takeaways from recent regulatory presentations on E6(R3) CHAPTERS 00:00 Intro 01:37 Topic and speaker intro 02:41 GCP Guideline - The history of ICH 05:03 ICH E6 R3 Overview - What's new and what's different 13:50 Enhanced key concepts 17:35 Essential records 24:05 Data Governance 28:57 Take home message 29:57 Question period 42:38 Wrap up and closing