Mark Harrison, AstraZeneca - Qepler Summits And Conferences

Mark Harrison

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

I have worked for AstraZeneca for 18 years within Operations, Global Medicines Development.

In my role as a Mass Spectrometry specialist leading pmi analysis and with a focus on extractable and leachable analysis.

My first degree is in Chemistry from Queen Mary University of London, and my I achieved my PhD in Pharmaceutical Chemistry from the The School of Pharmacy and Medicine, University of Bradford.

I have a wide range of international publications covering the areas of trace analysis, separation science, extractables and leachables, genotoxins analysis and mass spectrometry.

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
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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2nd Annual Genotoxic Impurities in
Pharmaceuticals Summit 2021

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 15 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 15 July 2021
CASE STUDY: Meeting the challenge of trace analysis of N-nitrosamines -The impact for the pharmaceutical industry.
  • The history of the N-nitrosamine challenge.
  • How has Industry met this challenge?
  • What are the practical measures needed to provide ultra-trace N-nitrosamine data?
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