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Andrew Teasdale

Principle Scientist
AstraZeneca
Fields of expertise: Chemicals
About The Speaker

Andrew Teasdale PhD has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. His current role is that of chair of AstraZeneca’s Impurity Advisory Board. He is a leading expert in key impurity areas, including mutagenic impurities (MIs), Elemental Impurities (EIs), Impurity qualification and Extractables and Leachables (E&Ls). As well as his role in AZ he has led many cross industry groups relating to the areas described; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Extractables and Leachables Safety Information Exchange (ELSIE) and Product Quality Research Institute (PQRI). The latter focused on the critical area of sulfonate ester formation and control. He is also the editor/author of the first book on the subject of Genotoxic Impurities: Genotoxic Impurities – Strategies for Identification and Control (Wiley). He is also the inventor of the purge factor concept now routinely used in the evaluation of the potential carryover of mutagenic impurities. Andrew has also published more than 40 papers focused on various aspects of impurity management across all of the subjects described as well as a regular speaker at international conferences relating to Impurities. Currently Andrew is involved in development of the purge concept as a software tool, Mirabilis ™; the development of the ICH M7 addendum table and leader of an initiative to develop a cross industry database relating to elemental impurities within excipients. He is the immediate past chair of the Joint Pharmaceutical Analysis Group (JPAG) and a member of the Royal Pharmaceutical Society – Pharmaceutical Sciences Expert Advisory Panel.

Experiance on Field

Chair of AstraZeneca impurities advisory group. Responsible for the development and oversight of policy relating to all impurity categories, including impurity qualification / genotoxic impurities / metals and extractables & leachables. Expert within the field of Genotoxic Impurities. Editor of the first book specifically focused on the subject matter : Genotoxic Impurities: Strategies for Identification and Control. Current activities include leading a cross industry group in the development of an addendum table to ICH M7, including specific limits for genotoxic reagents (analogous to that in place in ICH Q3C for solvents). Inventor of the purge factor calculation concept used in the risk assessment of genotoxic impurities. Currently the chair of the Extractables and leachables safety information exchange (ELSIE) materials group. Also chair of the Joint Pharmaceutical Analytical Group (JPAG). Expertise also within the within quality assurance and pharmaceutical analysis field. Extensive project management experience both internally and in relation to cross industry collaborations. Specialties: Evaluation and risk assessment of genotoxic impurities / metals and extractables and leachables. Analytical chemistry >15yrs experience as an analytical chemist. Chairman of the Joint Pharmaceutical Analytical Group (JPAG).


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