The 3rd Annual Impurities: Genotoxic and Beyond Summit 2019 is dedicated to the compliant implementation practice of ICH M7 and Q3D and novel strategies for mutagenic and elemental impurities.
Topics
Proved strategies on impurity characterisation, qualification and risk assessment
Compliant practical implementation of recent updates in ICH M7 and Q3D
Novel approaches for in silico genotoxity testing Choosing the right strategy associated with the future industry developments and changing regulatory environment
Regulatory, toxicology, analytical experience for efficient mutagenic and elemental impurity identification, monitoring and control in pharmaceutical products, drug substances/APIs and excipients
Considerations for genotoxicity assessment of peptide/protein-related and novel oligonucleotide-based biotherapeutics
Comprehensive extractables and leachables evaluation and its significance to pharmaceutical quality
Latest recommendations on genotoxicity assessment of nanomaterials
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