Dr. Andrew Teasdale, AstraZeneca - Qepler Summits And Conferences

Dr. Andrew Teasdale

Senior Principal Scientist / Head of Impurity Management & CMC Strategy
AstraZeneca is a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.

Andrew Teasdale, PhD, is a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca’s impurity advisory group.

Andrew has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE). Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™.

He also published a book addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control,’ (Wiley and Son) and is soon to publish as editor a book focussed on practical implementation of ICH quality guidelines.

Related Sessions:

3rd Annual Genotoxic Impurities
in Pharmaceuticals Summit 2023

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 09 Mar 2023
  • Virtual,
  • Pharma
Day 1: Thursday, 09 March 2023
CASE STUDY: N Nitrosamines – Complex – API like N Nitrosamines – current realities and threats
  • Brief outline of the evolution of issue of N Nitrosamines
    • Why the current challenges are very different and more significant than original challenges.
    • the shift from synthesis risk to formulation risk.
  • Current challenges
    • Defining acceptable intakes – a process or roulette?
    • Status of the Ames test / other options
    • Controlling levels of API like Nitrosamines – we can shift the bar but not move a mountain – the harsh realities
    • Analytical challenges – technical risks and capacity
  • The near future – the choices and implications for all concerned
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