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Session 3 Track 2: Unlocking the Value of ICH M11: Streamlining Authoring, Accelerating Review, and Enabling Content Reuse
Session Chair(s)
Madhavi Gidh-Jain, PhD
Global Head of Medical Writing and Document Management, Sanofi US, United States
ICH M11 is moving protocol development from document first workflows toward structured, reusable data flow. This session explores dynamic review, governance, and downstream reuse through sponsor, regulatory, and site and technology perspectives.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Analyze how ICH M11 can streamline structured protocol authoring and review
- Assess how structured protocol content can improve governance and downstream reuse
- Evaluate how ICH M11 can expedite regulatory review
Speaker(s)
ICH M11: Connecting Structured Authoring, Dynamic Review, and Downstream Reuse
Ron Fitzmartin, MBA
Principal Consultant, Decision Analytics, United States
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