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Session 7 Track 3: The Future of Regulatory Submissions: Innovation of the Possible using a Non-disruptive Framework
Session Chair(s)
Jared Lantzy, PMP
Executive Director, Global Regulatory Operations
Novavax, Inc., United States
Innovative advances for automating and exchanging submission data content within a recognized regulatory framework referencing M4Q-R2, SPQS, and PQ-CMC advances relative to eCTD v4.0. Collaboration, and transformation envelops eCTD v4.0 and its far-reaching implications. Technology may be disruptive and revolutionary but must be introduced in a non-disruptive way to a highly regulated environment. Innovation within the CTD / eCTD v4.0 framework including cloud computing provides exactly this vehicle for change.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify eCTD 4.0 as a non-disruptive solution to data exchange
- Evaluate updates about M4Q R2 and its relationship to eCTD 4.0 and plans for SPQS
- Prepare for PQ-CMC and recognize its relevance to eCTD 4.0
Speaker(s)
The Future of Regulatory Submissions Using eCTD 4.0 as a Non-disruptive Framework for Data Exchange
David Sidney Ross, MBA, MSc, PMP, RAC
AstraZeneca, United States
Senior Director, Regulatory Data and Submissions
The Future of CMC Submissions with ICH eCTD, M4Q R2, and SPQS
Rodrigo Palacios, MBA
F. Hoffmann-La Roche, Switzerland
Regulatory Policy Lead
Balancing Structured Data and Narrative for CMC
Sarah Pope Miksinski, PhD
Gilead Sciences, United States
Executive Director, CMC Regulatory Affairs
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