Update on the ICH E6 R3 Workshop on 13-14 July 2023

Following the revision of the ICH E6 R2 guideline on Good Clinical Practice (GCP) that aims to address the application of GCP to the increasingly diverse range of clinical trial types and data sources, ACT EU Priority Action 4 on GCP Modernisation held a Workshop on the ICH E6 R3 Public Consultation (principles and Annex 1) on 13 and 14 July 2023.

The two-day workshop included in-depth presentations on the principles of ICH E6 R3 and Annex I, panel discussions with relevant stakeholders and Q&As, namely:

  • An in-depth look at the Document Structure, Principles, Annex I, and Appendices
  • An overview of Annex II
  • A panel discussion with relevant stakeholders (representatives)
  • Breakout sessions for more in-depth discussions on ICH E6 R3 Public consultation with relevant stakeholders

The workshop was attended by multiple relevant stakeholders, including patients, healthcare professionals, assessors, inspectors, industry and academia.

A video recording of the workshop’s Day 1 will be published on the dedicated event page in due course.

A more extensive summary will be available in the next issue of this Newsletter.