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23 - 24 October 2018
Hotel Palace Berlin,


Thank you to everyone who attended the 2018 Genotoxic Impurities!

Build a complete strategy for potential genotoxic impurities in your pharmaceuticals

Regulations: Ironing out the creases of the ICH M7
  • MHRA perspective on interpreting the ICH M7: What regulators want to see
  • Get to grips with global genotoxic impurity guidelines
  • What's the feedback following the ICH M7(R1) and (R2) addendums?
  • Master purging as a control strategy for genotoxic impurity
In silico: How powerful are your predictions?
  • Hear industry case studies of in silico assessment 
  • Learn what to do with Out of Domain results and how
  • Gain expertise in ensuring prediction is not compromised by rogue positives
  • Explore the future of in silico prediction for genotoxic impurities
Analytical strategies: Down to parts per million
  • Take a look at novel methodologies for trace level analysis of genotoxic impurities
  • Current challenges and future opportunities in analytical methods 
  • Share experiences with method development and transfer for GTIs
  • Discover new instruments and technologies for control of potentially genotoxic impurities


Managing emerging mutagenicity risks: Late stage mutagenic impurity control within the atovaquone second generation synthesis

Dr. Neil Stevenson - Senior Investigator, GC - Global API Chem - UK, RD Platform Technology & Science, GSK

Teaching computers a little bit of chemistry by showing them a large number of chemical structures

Suman Chakravarti - Vice President, Chief Scientific Officer at Multicase

Analytical control strategies for mutagenic impurities: Current challenges and future opportunities

David P. Elder - David P. Elder Consultancy, UK
Andrew Teasdale - AstraZeneca, UK

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