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Session Chair(s)
Stephen Miller, PHD
CMC Lead, Office of New Drug Quality Assessment, CDER
FDA, United States
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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