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Session 10: Track 4: Moving Towards Future Regulatory Processes: The Cloud and Beyond
Session Chair(s)
Thomas Noto
Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
This session will provide an overview of state-of-the-art regulatory processes. We will highlight the opportunities for process improvement through the use of cloud-based eDMS and eCTD solutions, control of document delivery, text mining, etc. New technologies such as Natural Language Processing and Artificial Intelligence will be explored. We will also give an overview of current and future developments to connect structured and unstructured content with the goal to gain efficiencies, reduce repetitive tasks, and increase data quality and consistency.
Learning Objective : At the conclusion of this session, participants should be able to:Review a case study of cloud based eCTD and eDMS solutions to demonstrate ease of use building sequences with an integrated cloud-based solution- Discuss the challenges and rewards of moving an organization from traditional regulatory processes to efficient cloud-based processes
- Exchange ideas about the implications of AI for regulatory challenges and opportunities with other industry experts
Speaker(s)
AI on the rise - Digitally Transforming Pharma’s Regulatory Processes
Timm Pauli
PharmaLex , United States
Head of Regulatory Operations
Brave New Regulatory World: Digitally Transforming Pharma’s Regulatory Processes
Thomas Noto
Lexicon Pharmaceuticals, United States
Senior Director, Regulatory Operations
Cloud-Based eCTD: A Case Study
Heather Fisher, MS
Arivis, United States
Director, Regulatory Operations
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