ICH Q3E Guidelines and It’s Implications


22nd March 2021 | 10:00 am CET | Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca and Dries Cardoen, Team Leader of Study Directors Inhalation/topical/transdermal products at Nelson Laboratories, LLC |BOOK FREE SEAT FOR THIS WEBINAR

Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca

Andrew Teasdale is 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. Dr Teasdale is an expert within the field of Genotoxic Impurities as well as the editor of the first book specifically focused on the subject matter : Genotoxic Impurities: Strategies for Identification and Control. His 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. He is currently the chair of the Extractables and leachables safety information exchange (ELSIE) materials group. He is also Chair of the Joint Pharmaceutical Analytical Group (JPAG). His expertise also within quality assurance and pharmaceutical analysis field. With extensive project management experience both internally and in relation to cross industry collaborations. With specialties in Evaluation and risk assessment of genotoxic impurities / metals and extractables and leachables. He has more than 15yrs experience as an analytical chemist and is Chairman of the Joint Pharmaceutical Analytical Group (JPAG).

Followed by Dries Cardoen, Team Leader of Study Directors – Inhalation/topical/transdermal products at Nelson Laboratories, LLC

Dries Cardoen received his Ph.D. from the Faculty of Biology at the University of Leuven (Belgium) in 2011. After his academic career as a post-doctoral researcher, he started at Nelson Labs (formerly Toxikon Europe) in 2013 as study director in the Extractables & Leachables Department. From the start, he specialized in E&L projects of inhalation drug products. He is currently leading the team of study directors that is specialized in E&L testing of inhalation drug products and topical and transdermal drug products.

Sponsored by Nelson Labs

Nelson Labs, A Sotera Health company, is the leading, global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex problems. We have over 700 scientists, technicians, and service specialists who diligently perform more than 700 rigorous tests in 13 global laboratory locations.
Based in Belgium, Nelson Labs Europe specializes in providing premium Extractables & Leachables testing services to the pharmaceutical and medical device industries. We also support pharmaceutical companies across the globe in developing worldwide compliance testing strategies to qualify container/closure applications and pharmaceutical production equipment from an Extractables & Leachables perspective.


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