International Council for Harmonisation (ICH) - The ICH E6(R3) Guideline reaches Step 4 of the ICH Process
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2025
- doi: 10.58079/13yf4
info:eu-repo/semantics/openAccess
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adelage, « International Council for Harmonisation (ICH) - The ICH E6(R3) Guideline reaches Step 4 of the ICH Process », ELSIBI, ID : 10.58079/13yf4
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ICH E6(R3) principles and Annex 1 have been adopted on 6th January 2025 and published on the ICH website. This is a rewrite and reorganisation of the R2 version of the guideline on Good Clinical Practice (GCP), which provides a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. Further information can be found on the E6(R3) page, including the Guideline and the Step 4 Introductory Training Presentation....
