About
The regulatory environment for clinical trial reporting has changed significantly in recent years, creating new expectations for medical writers, regulatory affairs professionals, and clinical operations teams.

This webinar will provide a clear, practical overview of what key frameworks such as the EU Clinical Trials Regulation, ICH M11, EMA Policy 0070, and related FDA requirements mean in practice, and how to build compliance into the writing process from the start rather than treating it as a final-stage check.

The session will cover how these frameworks connect and interact, what they mean for modern clinical study report writing, and what practical steps teams can take to adapt. Topics will include structural changes in CSRs, anonymisation, machine-readable content, layperson summaries, workflow considerations, gap analysis, and tools that can support compliance across global submissions.

Whether you are new to this area or looking to update established processes, this session is designed to provide clear, actionable guidance you can apply to your next project.
When
Thursday, October 8, 2026 · 9:00 a.m. Eastern Time (US & Canada) (GMT -4:00)
Agenda
  • Why it matters now: the changing regulatory landscape and the consequences of non-compliance
  • The regulatory landscape: EUCTR, ICH M11, EMA Policy 0070, FDA requirements, and how they interact
  • Impact on CSR writing: structural changes, anonymisation, machine-readable content, and layperson summaries
  • Practical compliance strategies: workflows, gap analysis, tools, and global submission considerations
  • Q&A and open discussion
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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