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Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate
Session Chair(s)
Lauren Geary, PHD
Senior Director, GSC, Regulatory Writing and Submission Capabilities
Eli Lilly and Company, United States
This session explores how lean authoring streamlines clinical regulatory documents, debunks myths about reviewer preferences, and offers practical strategies and case studies to improve authoring and better serve both teams and regulators.
Learning Objective : Identify common misconceptions around regulatory reviewer preferences and practices in reviewing CSRs and Module 2 documents; Explain how to prepare well-informed and effective arguments to persuade cross-functional authoring teams to create leaner, more concise, user-focused, and automation-ready documents; Recognize how and when to implement successful change management practices at your own organization
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