ICH E6(R3) Annex 2 is moving forward as per ICH Assembly yesterday

ICH E6(R3) Annex 2 is moving forward as per ICH Assembly yesterday

Pierre Mermet-Bouvier Pierre Mermet-Bouvier

Pierre Mermet-Bouvier

eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning

发布日期: 2024年11月14日
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According to the Press Release of the ICH Assembly Meeting, Montréal, Canada, November 2024 published yesterday,

  • "The Draft ICH E6(R3) Annex 2 Guideline on “Good Clinical Practice (GCP)” reached Step 2a/b and was endorsed by the ICH Assembly. This Annex addresses the GCP considerations that arise from the increased use of a wider range of design elements and data sources and focuses on examples of trials that incorporate decentralised elements, pragmatic elements and/or real-world data (RWD)".

We cannot predict when it will be released on the ICH Web site (nothing this morning), but this endorsement by the ICH Assembly is a very good achievement.

  • ICH E6(R3) Principles and Annex 1 release may be delayed according to the volume of feedback received during public consultation.

Stay tuned.

https://www.ich.org/pressrelease/press-release-ich-assembly-meeting-montreal-canada-november-2024

Oleg Shevaldyshev

Clinical Research Quality Assurance and Quality Management Expert (GCP QA / QM) including Serious Breaches

2 周

Many thanks Pierre Mermet-Bouvier ! Assuming that the Principles and Annex 1 would require a full assembly, we will hardly get them before Q2 2025, right?

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