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Informa

23 - 24 October 2018
Hotel Palace Berlin,
Berlin

REIGNITE AND REVOLUTIONISE YOUR GENOTOXIC IMPURITY STRATEGIES

The brightest industry and regulatory minds shine a light on identification and control of GTIs

Book now to SAVE

Book by Friday,  21st September 2018 and save up to £100

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

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