As part of the published Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of ICH E6 as the global regulatory guideline for GCP, the ACT EU Priority Action – GCP Modernisation is conducting a Workshop on ICH E6 R3 (principles and Annex 1).

 The workshop aims to engage all stakeholders of ICH E6 R3, including but not limited to, patients, healthcare professionals, regulators, industry and academia.

The objectives of this workshop are to:provide an overview of key changes in ICH E6(R3);explain and summarise the changes compared to the public consultation version of ICH E6(R3), principles and Annex 1;provide a set of practical implications with a focus on GCP modernisation;enable discussion with stakeholders on implementation of ICH E6(R3).

In-person attendance will be limited due to room capacity, with the aim of ensuring balanced representation across all stakeholder groups.

 The meeting will be broadcast to facilitate broad participation.

No certificate of attendance will be issued for this event.