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Session 9 Track 2: Developing and Implementing the International CMC Data Standards to Improve the Post-Approval Change Process
Session Chair(s)
Maria Sagoua, MHA
Director of Regulatory Innovation
Accumulus Synergy, United States
CMC data is a critical piece of product assessment. Yet, no international data standard existed…until now. Learn how the DX-PQ Implementation Guide, FHIR, and technology can accelerate global regulatory activities like post-approval changes.
Learning Objective : - Define the current state of CMC data standardization
- Describe framework and elements of the forthcoming DX-PQ implementation guide
- Demonstrate how adopting data standards, reliance practices, and innovative solutions can improve regulatory processes like, CMC-related post-approval changes
Speaker(s)
Driving Efficiency in Post-Approval CMC Change Management with Structured, Standardized Data
Rita Algorri, PhD, MS
Amgen, United States
Senior Manager, Global Regulatory Affairs (CMC)
Lessons Learned from a Completed CMC Post Approval Change Reliance Project Pilot
Cynthia Ban
Sanofi, Canada
Global Head, Regulatory Affairs CMC, Vaccines