ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 - Public Consultation
As part of the 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, a multi-stakeholder workshop on ICH E6 R3 public consultation is being organised by ACT EU Priority Action 4 (PA4). The workshop is fully virtual.
The first session on 13 July will begin at 13:30 CEST until 18:10 CEST. The session will be live broadcast. The session will include a welcome address by EMA's Executive Director, presentations by the Rapporteur and Regulatory Chair of the ICH E6 R3 Expert Working Group (EWG), in-depth presentations on both the principles of ICH E6 R3 and Annex I, panel discussions with relevant stakeholders and multiple Q&A sessions.
The second session on 14 July will run from 10:00 CEST until 15:30 CEST and will focus on discussions in multiple breakout sessions. This day will not be publicly broadcast, and pre-registration will be required. Day 2 will not be recorded. The breakout sessions will run on multiple different tracks held simultaneously, twice during the day, allowing relevant stakeholders to attend different breakout sessions if there are two topics of interest they would like to attend.
The registration process and the outlines of the agendas are available below. Please note the agenda may be subject to change.
The workshop aims to engage all stakeholders of ICH E6 R3, including but not limited to, patients, healthcare professionals, assessors, inspectors, industry and academia.
Registration is now open until 16 June 2023.
Please follow this link to register: https://ec.europa.eu/eusurvey/runner/ICHE6R3Workshop