3rd Annual Impurities: Genotoxic and Beyond Summit
12-13

June 2019

Munich

Germany

About

We are pleased to invite you to the 3rd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 12-13 2019 in Munich, Germany. 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 a...

We are pleased to invite you to the 3rd Annual Impurities: Genotoxic and Beyond Summit scheduled for June 12-13 2019 in Munich, Germany. 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 Munich in June!

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Who Should Attend

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

  • Analytical Science
  • Assay Development
  • Chemistry (Analytical, Organic, Medicinal, Protein)
  • Drug Design
  • Drug Discovery
  • Extractables and Leachables
  • Genetic Toxicology
  • Genotoxin
  • Good Laboratory Practice
  • In Silico
  • LC-MS
  • Microscopy
  • Nanomaterials
  • Oligonucleotide
  • Particles
  • Pre-Clinical Drug Safety
  • Protein
  • Quality Assurance
  • Quality Control
  • Research and Development
  • Small Molecule
  • Technology Transfer
  • Validation
  • API Development
  • Biotherapeutics
  • Chromatography
  • Drug Development
  • Elemental Impurities
  • Formulation
  • Genotoxic Impurities
  • GMP
  • Impurities
  • Large Molecule
  • Mass Spectrometry
  • Mutagenic Impurities
  • Nanoparticles
  • Organic Synthesis
  • Peptide
  • Process Chemistry
  • Purification
  • Quality by Design (QbD)
  • Regulatory
  • Safety Assessment
  • Spectroscopy
  • Toxicology
Key Practical Learning Points of the Summit

Compliant practical implementation of recent updates in ICH M7 and Q3D
Proved strategies on impurity characterization, 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 & leachables evaluation and it’s 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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