€1,445.95 – €1,929.95

4th Annual Impurities: Genotoxic and Beyond Summit

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Eurostars Roma Aeterna

Via Casilina, 125, Piazza del Pigneto, 9a, 00176 Roma

00176 Rome

Italy

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This summit will shed light on the compliant implementation practice of ICH M7 and Q3D and novel strategies for efficient mutagenic

About this Event

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.

KEY PRACTICAL LEARNING POINTS

  • Recent experience and perspectives on 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
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Location

Eurostars Roma Aeterna

Via Casilina, 125, Piazza del Pigneto, 9a, 00176 Roma

00176 Rome

Italy

View Map

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