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#552: Optimizing the Content Ecosystem Through Lean Authoring: A Framework to Meet Regulatory Expectations and Prepare to Automate
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-26-587-L04-P; CME 1.00; RN 1.00

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 Objectives

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

Chair

Lauren Geary, PHD

Speaker

Panelist
Inger Oedum Nielsen, PHD, MS


Speakers
LG

Lauren Geary

Senior Director, GSC, Regulatory Writing and Submission Capabilities, Eli Lilly and Company, United States
As the Sr. Director of Regulatory Capabilities and Submissions at Eli Lilly, I am responsible for ensuring functional proficiency in regulatory medical writing. Leveraging my medical training at the USC Keck School of Medicine, and regulatory training and experience in clinical trial... Read More →
avatar for Inger Nielsen

Inger Nielsen

Associate Director, Novo Nordisk A/S, Denmark
Inger Ødum Nielsen is Associate Director in Content Innovation and Management, Clinical Reporting at Novo Nordisk, where she leads a team focused on driving digital transformation in clinical reporting. She has a strong track record of operationalising digital tools into the line... Read More →
Tuesday June 16, 2026 4:15pm - 5:15pm EDT
105AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  04: MedAffairs-SciComm, Session |   08: RegPolicy-Strategy-GlobalCollaboration, Session |   06: ProfDevelop-Program-PortfolioMgmt, Session
  • Audience Intermediate
  • Level Intermediate
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Medical Affairs & Scientific Communication,Regulatory
  • Tags Session

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