About
Important note: To maintain a focused and interactive format, live attendance is limited and registration is subject to approval.

As protocol writing moves from narrative drafting toward structured, machine-readable content, ICH M11 is reshaping how protocols are developed, reviewed, and reused across the clinical development lifecycle. This session will explore what that shift means in practice for medical writers and cross-functional teams.

Led by Shiri Diskin, PhD, Chief Medical Writing Officer at Bioforum, the session will cover the core principles behind ICH M11 and CeSHarP, the structural and operational changes introduced by the new template, and practical implementation guidance for writers working in this evolving environment.

When
Wednesday, July 1, 2026 · 9:00 a.m. Eastern Time (US & Canada) (GMT -4:00)
Agenda
  • Introduction to ICH M11 and CeSHarP
  • What’s changing in protocol writing under M11
  • Key template updates and implementation of E6(R3) principles
  • Practical implications for medical writers
Presenter
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Shiri Diskin
Chief Medical Writing Officer
Shiri holds a PhD in Cell, Molecular and Developmental Biology from Tufts University, USA, and has worked in medical writing since 2009. She served as a medical writer and team leader at Teva until 2014, and has since worked as an independent medical writing consultant and instructor.

Shiri has extensive experience managing medical writing projects across early and late-stage product development. Her expertise includes study-level documents such as protocols and clinical study reports, as well as program-level documents including investigator’s brochures and summaries of efficacy and safety.

She works closely with cross-functional clinical development teams, including safety, biostatistics, and data management, to deliver high-quality, clear, and regulatory-compliant documents on time. In addition to regulatory writing, Shiri is also an expert in scientific publications, supporting manuscript writing and editing and leading workshops for physicians and scientists. Her book on scientific writing was recently published worldwide.
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