ACT EU workshop on ICH E6 R3 (principles and Annex 1)

• Date:
  Wednesday, 19 February 2025, 09:30 - 18:00 Amsterdam time (CET)
  Thursday, 20 February 2025, 09:30 - 14:00 Amsterdam time (CET)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands
  Live 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.  

Submit questions in advance

We encourage event participants to use Slido and to submit questions in advance of the webinar (use code: #ACTEUworkshop). The questions submitted in advance of the event will be answered by speakers during the panel session. 

Questions not addressed during the event will not be answered in a post-mailing.

Please submit your questions by February 10, 2025, via Slido:

• Slido

Documents

Agenda - ACT EU workshop on ICH E6 (R3)

Live broadcast

Due to the high interest, participants joining remotely can follow the workshop through broadcast. No pre-registration is required and the link will be published on this website.

Invitations for in person participation have been sent.