ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 - Public Consultation
Table of contents
Date:
13/07/2023 to 14/07/2023
Location:
Online and European Medicines Agency, Amsterdam, the Netherlands
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 first session includes:
- 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,
- multiple Q&A sessions.
The second session comprises of discussions in multiple breakout sessions.
The workshop aims to engage all stakeholders of ICH E6 R3, including but not limited to, patients, healthcare professionals, assessors, inspectors, industry and academia.
Please note that no certificate of attendance will be submitted
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Agenda - ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 (PDF/314.61 KB)
Draft
First published: 26/05/2023
Last updated: 07/07/2023 -
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Meeting report - Multi-stakeholder Workshop on ICH E6(R3) - Public Consultation - Day one (PDF/189.17 KB)
First published: 29/08/2023
EMA/321989/2023