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ICH Update: Emerging Guidelines
Session Chair(s)
Stephen Miller, PHD
CMC Lead, Office of New Drug Quality Assessment, CDER, FDA, United States
This session will provide an update on the current thinking for safety assessment and control of elemental impurities and mutagenic impurities in pharmaceuticals.
Learning Objective : Identify the current thinking for safety assessment and control of elemental impurities and mutagenic impurities in pharmaceuticals.
Speaker(s)
Mark G. Schweitzer, PHD
Global Head, Analytical Science and Technology, Novartis Pharmaceuticals Corporation, United States
ICH Q3D Update: Looking Ahead to a Globally Harmonized Approach to Elemental Impurities
Alisa Vespa, PHD
Senior Scientific Evaluator/Safety Subject Matter Expert, Risk Management Divisi, Health Canada, Canada
ICH M7: Mutagenic Impurities- Safety Considerations
Stephen Miller, PHD
CMC Lead, Office of New Drug Quality Assessment, CDER, FDA, United States
ICH M7: Mutagenic Impurities - Chemistry, Manufacturing, and Controls Aspects
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