DIA RSIDM 2025
イベント・学会参加情報
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
講演者
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
Additional Resources
