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Session 3B: Impurities - Genotoxic Impurities
Session Chair(s)
Stephen Miller, PhD
CMC Lead, Office of New Drug Quality Assessment, CDER
FDA, United States
Genotoxic compounds may be used as synthetic intermediates, reagents, etc, or may be formed as by-products during the manufacture of pharmaceuticals. Maintaining any genotoxic impurities at or below levels that are acceptable presents challenges to industry and to regulators due to the need for highly sensitive analytical methods, and the diversity of structures and reactivity. This session will present current approaches under consideration for an ICH guideline, and discuss experience from both the industry and regulatory perspectives on the control of genotoxic impurities in pharmaceuticals.
Speaker(s)
Genotoxic Impurities: EU Experience and Comparison with the Current Discussion at ICH
Jean-Louis Robert, PhD
Luxembourg
Former CHMP/CVMP QWP Chair
Genotoxic Impurities - An Industry Perspective
Kate Arnot, MSc
AstraZeneca, United Kingdom
Regulatory CMC Director
Genotoxic Impurities as Critical Quality Attributes
Stephen Miller, PhD
FDA, United States
CMC Lead, Office of New Drug Quality Assessment, CDER
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