ICH E8(R1) General Considerations for Clinical Studies

On 28 April 2022 the ICH announced that Step 4 - Introductory Training Presentation – is available on the ICH website.

This document has been signed off as Step 4 document (6 October 2021) to be implemented by the ICH Regulatory Members. This document was developed based on a Concept Paper (14 November 2017) and Business Plan (14 November 2017).

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /