As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 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 organising 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)
To register for participation, please complete the EU survey via this link by COB December 10, 2024.
In the survey, you can indicate if you wish to attend the event in person or online. Please be aware that in-person attendance will be limited due to room capacity, with the aim of ensuring balanced representation across all stakeholder groups.
The meeting will also be broadcast to facilitate broad participation. For more information, please visit the event’s webpage.