4th Annual Impurities: Genotoxic and Beyond Summit
03-04

June 2020

Italy

Milan

About

We are pleased to invite you to the 4nd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 3rd-4th, 2020. This premier B2B event provides the appropriate platform to engage and discuss ideas with your peers, while facilitating a professional atmosphere and environment for good company representation and development. The Summit will shed light on the compliant implementation practice of ICH M7 and Q3D and novel strategies for efficient mutagenic and elemental impurities identification and control. It is an honour and privilege to...

We are pleased to invite you to the 4nd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 3rd-4th, 2020. This premier B2B event provides the appropriate platform to engage and discuss ideas with your peers, while facilitating a professional atmosphere and environment for good company representation and development. The Summit will shed light on the compliant implementation practice of ICH M7 and Q3D and novel strategies for efficient mutagenic and elemental impurities identification and control. It is an honour and privilege to invite you to participate in this Summit. We look forward to welcoming you in June!

more info
Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders and Managers specialising in:

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

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

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