ICH M11 Expert Working Group publishes final overview presentation

18th May 2026

Summary:
The International Council for Harmonisation (ICH) M11 Expert Working Group has released its final overview presentation to support understanding and implementation of the M11 guideline. This guideline focuses on standardising the structure and content of clinical study protocols, helping to improve consistency, efficiency, and quality across global clinical trials. The presentation provides key insights into the guideline’s objectives, core components, and expected benefits for sponsors and regulators. By promoting a harmonised approach, M11 aims to streamline protocol development and facilitate better communication between stakeholders.

Link: https://www.ich.org/news/ich-m11-expert-working-group-issues-final-overview-presentation

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