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Session 8, Track 1: Regulatory Submission Revolution: Insights into eCTD 4.0, Agile Governance and AI-Driven Document Migration
Session Chair(s)
Shenqi (Handsome) Ji
Regional Publishing Lead, Asia, Global Regulatory Operations
Pfizer, China
This session will delve into key technological advancements in regulatory submissions and document management. It will explore the technical refinements of eCTD 4.0, offering clarity on specialized outputs for successful submissions. Explaining the impact of artificial intelligence (AI) and machine learning (ML) in automating legacy migration from documents to data components. Furthermore, the session will emphasize the importance of an agile governance structure across systems, ensuring accurate data transfer to RIM systems and streamlined processes for effective submission management.
Learning Objective : - Identify key differences between eCTD 4.0 and 3.2.2, focusing on file/folder structure and XML review
- Share how data governance enables seamless data transfer between RIM systems and other systems, ensuring that data is consistent, accurate, and accessible across all systems
- Explain the benefits and cost savings of natural language processing (NLP) and AI-driven data parsing for document conversion
Speaker(s)
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