ACT EU workshop on ICH E6 R3 (principles and Annex 1)
Event
Human
Clinical trials
- The original event times are:
- Wednesday, February 19, 2025 - 09:30 - 18:00 Amsterdam time (CET)
- Thursday, February 20, 2025 - 09:30 - 14:00 Amsterdam time (CET)
Date
- , -, -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive broadcast
Event summary
As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2024-2026 and acknowledging the important role of international Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Efficiency Guideline 6 (E6) as the global regulatory guideline for Good Clinical Practice, the ACT EU Priority Action – GCP Modernisation is conducting a Workshop on ICH E6 R3 on 19 and 20 February 2025.
The workshop aims to engage all stakeholders of ICH E6 R3, including but not limited to patients, healthcare professionals, including investigators, regulators, service provider, ethics committees members industry and academia.
The objectives of this workshop are to:
- provide an overview of the major changes in the ICH E6(R3) guideline, including changes from the draft version of the ICH E6(R3) guideline that was published for public consultation;
- highlight key concepts for adaptation of Good Clinical Practice to recent developments in trial design, organisation and technology, and how these will help to future-proof the guideline;
- enable discussion with stakeholders on the implementation of ICH E6(R3).
This is a hybrid workshop, with the ability to attend in person and remotely. In-person attendance will be limited due to room capacity, with the aim of ensuring balanced representation across all stakeholder groups.
Report
Workshop report is available here: Workshop report on ICH E6(R3) principles and annex 1
Agenda
Video recording