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ICH M11 Protocol Template and Its Impact on Clinical Development
Who it is for
Open to EMWA members registered for the EMWA Autumn Conference 2026.
What it covers
ICH M11 introduces the first internationally harmonized clinical protocol template supported by regulatory guidance and a technical specification. Applicable across all phases and therapeutic areas, it provides a common structure, terminology, and conventions for protocol development while maintaining the flexibility needed to support diverse trial designs and regional requirements.
Beyond standardizing protocol content, ICH M11 lays the foundation for a shift from document-centric to data-centric clinical development. By representing protocol information as structured, labelled data elements, it can enable interoperability, content reuse, electronic exchange, and more predictable AI-enabled content generation. Sponsors can adopt ICH M11 incrementally, beginning with structured Word or PDF protocols and progressing toward fully digital implementation.
This session will provide a practical introduction to ICH M11, covering its scope, key principles, and considerations for protocol users. It will also explore how ICH M11 can act as a catalyst for transformation in clinical development, advancing protocol harmonization and enabling the digital future of clinical trials designs and execution.
ICH E(R3) - impact for Medical Writing
ICH GCP is now final with the advent of the consolidated guideline in June this year. What are the main themes that have changed from Revision 2? What is the impact for medical writers? How does this dovetail together with M11?
Rebecca Stanbrook is the Founder and Director of RESaltas GmbH, a specialist GCP and pharmacovigilance consultancy based in Muttenz, near Basel. She has worked in the pharmaceutical sector for over thirty years, as a regulator and in industry.
She spent eleven years at the MHRA, latterly as Group Manager for the GCP, Pharmacovigilance and GLP Inspectorates, where she was closely involved in establishing the UK risk-based statutory inspection programmes. Her teams at the MHRA wrote the Good Clinical Practice Guide and the Good Pharmacovigilance Practice Guide. She then spent twelve years at Novartis, in a variety of roles, latterly as GCP Strategic Lead in the Process, Risk and Surveillance team.
Rebecca is a member of the ICH Expert Working Group that authored ICH E6(R3), serving as EFPIA Topic Lead. She is a pharmacist by profession and holds a Diploma in Research Quality Assurance.
Through RESaltas she delivers mock inspections, GCP and pharmacovigilance training, and regulatory strategy support.
Alexey is a Principal Regulatory Content Strategist at Roche Pharma, with over 14 years of experience in medical writing, including both scientific publications and global regulatory documents. As a protocol subject-matter expert, he has been involved in applying ICH M11 standards to the Roche protocol template and introducing novel AI-based tools for protocol development. Alexey has a deep research background in molecular and cellular biology, combined with a passion for applying novel technologies to regulatory documentation development.
Geetha brings over 19 years’ experience in medical writing, publication development and clinical trial transparency. She has spent her entire career at GSK, progressing from individual contributor roles to leadership. A former Global Process Owner for the protocol process, she currently serves as Medical Writing Therapy Area Head and as EFPIA deputy topic lead on the ICH M11 expert working group. Geetha combines deep technical expertise with a strong commitment to harmonization, a passion for process simplification, and the pragmatic application of technology to improve quality and efficiency.
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The conference registration fee (€50) must be in your basket before any session can be added. It is one off and covers the opening session and the plenary.
Terms and conditions
Changes to registration
Changes may be made to workshop or seminar choices after booking (that is, a cancellation of one workshop or seminar choice and replacement by another), for an administrative fee of €27, plus any difference in price between the choice of workshops or seminars. Workshops, seminars and lunchtime sponsored sessions may be added to your original registration (subject to availability) at any time, without an administrative fee by contacting info@emwa.org. All changes are subject to availability.
Cancellation of attendance
If you wish to cancel your attendance at the conference, a refund, minus an administration fee of €162, will be made provided your cancellation is made in writing to EMWA head office before 20 October 2026. No refunds will be made after this date.
Payments
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