Mark Harrison, AstraZeneca - Qepler Summits And Conferences

Mark Harrison

Principal Analyst
AstraZeneca
Sheffield, United Kingdom
AstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.

Related Sessions:

Genotoxic Impurities in
Pharmaceuticals Summit 2019

GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 11 Apr 2019
  • Berlin, DE
  • Pharma
Day 1: Thursday, 11 April 2019
BLOCK:
CASE STUDY: ICH M7 and potential mutagenic impurities; control strategy, analysis and regulatory response.
  • Considerations in a risk assessment and technical position statement.
  • Desired qualities for PMI analytical methodology.
  • When is it applicable to use ICH M7 option 4?
  • Current regulatory challenges
  • Examples of regulatory communications/discussions
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