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ICH GCP E6 R3 draft guideline: main changes and clarifications

Written by Emanuela Ferrigno | Jul 27, 2023 3:23:12 PM

The ICH GCP E6 Working Group published the draft of the ICH GCP E6 R3 Guidance on May 19th, 2023. Stakeholders have the opportunity to provide comments on the guideline until September 26th, 2023 by using the template available on the EMA website.

 

What is the purpose of the Guideline? 

The Guideline aims to adapt the GCP E6 to the evolution of new study designs and to the innovative technologies being used.