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DIA RSIDM 2025

DIA RSIDM 2025

Session 8, Track 1: Regulatory Submission Revolution: Insights into eCTD 4.0, Agile Governance & AI-Driven Document Migration

Session Chair: Shenqi (Handsome) Ji, Regional Publishing Lead, Asia, Global Regulatory Operations, Pfizer, China

演讲嘉宾:
Diving into eCTD v4.0: Examination of the Technical Changes to the eCTD Structure
Rachel Bombara, Certara, United States, Sr. Regulatory Services Manager

Governance Structure, a Potent Tool to Sync Data and Processes Across Systems for Effective End-to-end Submission Management
Wim Dhaeze, PhD, Sarepta Therapeutics, Inc., United States, Senior Director, Regulatory Operations, RIMS/DMS Lead

Turn Documents to Data and Future-Proof Your Information
Ryan Adamson, Glemser Technologies, United States, Director, Operations

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