ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3 - Public Consultation

• Date:
  Thursday, 13 July 2023, All day
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

As part of the 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

Documents

Agenda - ACT EU PA04 - Multi-stakeholder Workshop on ICH E6 R3

Draft

Meeting report - Multi-stakeholder Workshop on ICH E6(R3) - Public Consultation - Day one

Reference Number: EMA/321989/2023

Video recording