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AI-Enabled Structured CMC Submissions: Leveraging Cloud Technology for Enhanced Collaboration and Analysis
Session Chair(s)
Ciby Joseph Abraham, PHD
Senior Director and Group Manager, Project and Product Leadership
AstraZeneca, United States
The session will show CMC data from an internal system can be transferred to a cloud environment. The session will include a demonstration of structured CMC submissions and show how AI-assisted tools can facilitate review and collaboration.
Learning Objective : Illustrate a future state in which CMC data from internal systems can be seamlessly transferred to a cloud environment; Demonstrate a structured CMC submission and show how AI-assisted tools can facilitate review and collaboration between industry and regulators.
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