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Session 9, Track 3: Enabling Efficient Regulatory Submissions: A Cloud-Based Approach to Structured CMC Dossiers
Session Chair(s)
J Paul Kirwan, PhD, MSc
Senior Manager, Regulatory Affairs, Amgen, United States
This session will provide an in-depth overview and demonstration of the CMC use case within Project PRISM, illustrating progress in digital CMC submissions. Participants will see the workflow beginning with the submission of a CMC dossier in PDF format to a secure, cloud-based environment. Advanced AI tools are employed to deconstruct the PDF, extract unstructured CMC data, and convert it into a structured dataset based on a CMC data standard. The demonstration will highlight how leveraging structured data reduces manual effort and builds a foundation for faster, more reliable regulatory submissions and review.
Enabling Efficient Regulatory Submissions: A Cloud-Based Approach to Structured CMC Dossiers
Ciby Joseph Abraham, AstraZeneca
Vada Perkins, Boehringer Ingelheim
Omar Serang, DNAnexus
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand how AI tools can extract and structure CMC data from PDF submissions to support digital transformation in regulatory processes
- Identify how cloud-based platforms enable real-time collaboration, data traceability, and integrity throughout the CMC dossier lifecycle
- Discover how structured data approaches can reduce manual effort and potentially accelerate reviews
Speaker(s)
Enabling Efficient Regulatory Submissions: A Cloud-Based Approach to Structured CMC Dossiers
Ciby Abraham, PhD
Executive Director, CMC Regulatory Affairs, Merck& Co., Inc., United States
Speaker
Rune Bergendorff, MSc
Partner, International Life Sciences, Implement Consulting Group, Denmark
Speaker
Omar Serang
Chief Cloud Officer, DNAnexus, United States
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