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
