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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

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

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


Rita  Algorri, PhD, MS

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)

Cynthia  Ban

Lessons Learned from a Completed CMC Post Approval Change Reliance Project Pilot

Cynthia Ban

Sanofi, Canada

Global Head, Regulatory Affairs CMC, Vaccines

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