Annual Impurities: Genotoxic and Beyond Summit


The Annual Impurities: Genotoxic and Beyond Summit is dedicated to the compliant implementation practice of ICH M7 and Q3D and novel strategies for mutagenic and elemental impurities.

The Annual Impurities: Genotoxic and Beyond Summit covers topics such as:

  • 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

The Annual Impurities: Genotoxic and Beyond Summit brings together 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

Future Events

Past Events


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions