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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)
ICH Q3D Update: Looking Ahead to a Globally Harmonized Approach to Elemental Impurities
Mark G. Schweitzer, PhD
Novartis Pharmaceuticals Corporation, United States
Global Head, Analytical Science and Technology
ICH M7: Mutagenic Impurities- Safety Considerations
Alisa Vespa, PhD
Health Canada, Canada
Senior Scientific Evaluator/Safety Subject Matter Expert, Risk Management Divisi
ICH M7: Mutagenic Impurities - Chemistry, Manufacturing, and Controls Aspects
Stephen Miller, PhD
FDA, United States
CMC Lead, Office of New Drug Quality Assessment, CDER
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