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4th Annual Impurities: Genotoxic and Beyond Summit

Recent experience and perspectives on the compliant implementation of ICH M7 and Q3D

This premier B2B 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 honor and privilege to invite you to participate in our Summit. Don’t miss out on this opportunity to discuss ideas with your peers while being part of a professional atmosphere and environment for good company representation and development.   

  • Recent experience and perspectives on the compliant implementation of ICH M7 and Q3D
  • Risk assessment of potentially genotoxic impurities and safety testing: critical issues and best practices for regulatory submissions
  • Extractables and leachables, elemental impurities in drugs and biologics: quality concerns, recommendations for comprehensive evaluations, upcoming changes in standards and regulations
  • Regulatory, toxicology, analytical practice 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
  • Valsartan incident and its implications for ICH M7


15 Sep 2020 @ 12:00 am

16 Sep 2020 @ 12:01 am

Duration: 1 days


Eurostars Roma Aeterna

125 Via Casilina

00176 Roma


Organised by

Vonlanthen Group

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