Day 3 Session 1 - GCP R3loaded: How ICH E6 R3 is Reshaping the TMF Landscape
Автор: Montrium
Загружено: 2025-07-16
Просмотров: 148
Описание:
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
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