3rd Annual Impurities: Genotoxic and Beyond Summit 2019

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

Who should Attend

Attendees involved or interested in:

• API Development
• ADC (Antibody Drug Conjugates)
• Carcinogens
• Biotherapeutics
• DNA Reactive Impurities
• Chromatography
• Drug Discovery
• Drug Design
• Extractables & Leachables
• Drug Substance
• Genotoxicity
• Genetic Toxicology
• GRAs
• GMP
• Large Molecule
• Impurities
• Mutagenic Impurities
• Mass Spectrometry
• New Modality
• Nanomaterials
• Peptide
• Organic Synthesis
• Process-Related Impurities
• Pre-Clinical Drug Safety
• Purge Factors
• Protein
• Regulatory
• Quality by Design (QbD)
• Spectroscopy
• Safety Assessment
• Toxicology
• Technology Transfer
• Analytical Science
• Carcinogenic Impurities
• Assay Development
• Degradation Products
• Chemistry (Analytical, Organic, Medicinal, Protein)
• Drug Development
• DNA Reactivity
• Elemental Impurities
• Drug Safety
• Genotoxic Impurities
• Formulation
• Good Laboratory Practice
• Genotoxin
• In Silico
• GTIs
• Microscopy
• LC-MS
• Nanoparticles
• Mutagenicity
• Particles
• Oligonucleotide
• Process Chemistry
• PGTIs
• Purification
• Product-Related Impurities
• Quality Control
• Quality Assurance
• Small Molecule
• Research and Development
• Threshold of Toxicological Concern (TTC)
• TDI
• Validation