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

Annual Impurities: Genotoxic and Beyond Summit 2020

Important

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

Prices are for evaluation only.

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