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Predictive Stability– How Do We Move To A Risk Based Approach For Providing Required Stability Data, Platform Data, Extrapolation etc Linking Bio/Chemical Approaches By Science
Session Chair(s)
Julia Claus
CMC Regulatory
Pfizer, United Kingdom
Carolyn Gordon, PhD
Senior Director, Regulatory CMC, Global Regulatory Affairs
AstraZeneca, United Kingdom
This session will focus on the uses of predictive stability techniques throughout the lifecycle of a drug. We will discuss how their use enhances our understanding allowing us to bring potential new medicines to the clinic and to patients as earlier. We will demonstrate and discuss their many uses, including how predicted degradation pathways allow us to set shelf lives, how they can help us to understand the potential impact that changes to drug substance or drug product manufacturing processes have on stability, or how temperature excursions in the supply chain affect the final drug product.
Speaker(s)
Accelerated Predictive Stability (APS); A Small Molecule Perspective
Sabine Thielges, DrSc
Novartis, Switzerland
Stability expert
Risk-based Predictive Stability for Biologics; A Biopharma Industry Perspective
Andrew Lennard, PhD, MS
Amgen, United Kingdom
Regulatory Affairs CMC
Stability Requirements in Accelerated Schemes; Regulatory Perspective on Stability of Biological Products
Mats Welin, MPharm
Medical Products Agency (MPA), Sweden
Senior Expert
Panelist
Blanka Hirschlerova, MSc
State Institute for Drug Control, Czech Republic
Senior Pharmaceutical Assessor
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