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CORE Reference Webinar
Wednesday 17th June @ 13.00-13.50 CET
Our next CORE Reference webinar will be presented by Marcie Roche (Argenx) who will share her insights in ICH M11, More details to follow. Register in advance for this webinar:
Title: ICH M11: an integrated and forward‑looking CeSHarP perspective
Abstract: Viewed through a regulatory medical writing lens, ICH M11 (CeSHarP [Clinical Electronic Structured Harmonised Protocol]; adopted 19 November 2025) reframes clinical study protocols as structured, reviewable, and reusable source documents that preserve scientific intent and decision-making transparency. The harmonised template and technical specification reduce variability, support interoperable electronic exchange, and minimise unnecessary repetition through consistent content placement.
With the convergence of established industry approaches, TransCelerate’s Common Protocol Template (V11, 2026) was realigned to ICH M11, reflecting a reconciliation of legacy authoring practices with emerging global standards that support operational efficiency and submission readiness.
While CPT V11 reflects the ICH M11 protocol template and associated technical specification, the level of detail and content implementation requires medical writing judgment beyond simple adherence to the template.
Within the clinical study documentation continuum, disciplined lean authoring, traceability, and the critical evaluation of content for use or AI‑assisted text remain essential to ensure that protocol decisions remain aligned with downstream reporting (as reflected in the CORE Reference framework).
This webinar encourages medical writers and regulatory professionals to take a deliberate, forward‑looking approach to their craft, recognising that precise structure and clear intent are essential to scientific integrity and effective communication.
Bio: Marcie A. Roche, PhD is a senior director of medical writing at argenx with over 20 years of pharmaceutical industry experience. She promotes the strategy and development of clinical and regulatory documents that support global health authority submissions and related agency interactions. Her work prioritises clear, consistent, guideline-aligned content that integrates complex concepts into lean authoring narratives, valuing cross-functional leadership and mentoring medical writers.
After registering, you will receive a confirmation email containing information about joining the meeting.
