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Prior Knowledge - How Experience of the Past Can Drive the Future: Patient-Centric Specs ICH Q6, Predictive Stability, Modeling ICH Q1/5C
Session Chair(s)
Celeste Frankenfeld Lamm
Senior Director, Global Regulatory Affairs – CMC
Merck Sharp & Dohme LLC , United States
This session will delve into how prior knowledge can be used to support decision making and development in the CMC dossier. Specifically, how prior knowledge can support patient centric specifications and predictive stability will be explored.
Learning Objective : Define prior knowledge (in the context of CMC submissions; Appraise what prior knowledge may be meaningful in supporting patient centric specifications and predictive stability; Justify how prior knowledge may reduce regulatory burden.
Speaker(s)
Industry Perspective: Prior knowledge to Inform Specifications and Control Strategy
Sarah Demmon
Eli Lilly, United States
Vice President
Regulatory Perspective
Ingrid Markovic, PhD
FDA, United States
Senior Science Advisor, Office of the Center Director, CBER
Overview of ICH Q6
Andrew Chang, PhD
Novo Nordisk, United States
Vice President, Quality and Regulatory Compliance
Industry Perspective: Prior Knowledge, Advanced Kinetic Modeling for Stability, and ICH Q1/5C
Warren Roche
Sanofi, Ireland
Statistician
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