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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
Publishing Regional Director, Asia, Global Regulatory & International 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.
Diving into eCTD v4.0: Examination of the Technical Changes to the eCTD Structure - Rachel Bombara, Certara
Governance, a Potent Tool to Sync Data and Processes Across Systems for Effective End-to-End Submission Management - Wim Dhaeze, Sarepta Therapeutics, Inc
Turn Documents into Data and Future-Proof Your Information - Ryan Adamson, Glemser Technologies
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)
Rachel Bombara
Sr. Regulatory Services Manager, Certara, United States
Diving into eCTD v4.0: Examination of the Technical Changes to the eCTD Structure
Wim Dhaeze, PHD
Senior Director, Regulatory Operations, RIMS/DMS Lead, Sarepta Therapeutics, United States
Governance, a Potent Tool to Sync Data and Processes Across Systems for Effective End-to-End Submission Management
E. Ryan Adamson
Director, Operations, Glemser Technologies, United States
Turn Documents into Data and Future-Proof Your Information
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