Dr. Laurence J. Harris joined Pfizer in Sandwich, UK, in 1999 as a process development chemist in chemical research and development (CRD), where he led project teams, API technology transfer, new API technology, and green chemistry implementation programs. In 2008 he joined the analytical research and development (ARD) department in a team leader role before moving into the GMP analytics function of ARD. He is currently a director within the global GMP analytics function with responsibilities for stability testing, drug product release, excipients, and packaging component release. Since 2014 he has been leading Pfizer worldwide research and development efforts to understand and fully implement ICH Q3D into the development workflow. This role has resulted in him becoming a key contributor to the cross-industry consortium working towards delivering and using the Lhasa elemental impurities excipient database in ICH Q3D risk assessments. Since 2019 he has been the industry co-chair for the Lhasa/industry consortium.

Trish Parris joined Pfizer in February 2020 as a global risk assessment services toxicologist in drug safety R&D. Trish has a background in genetic toxicology and, over the last 12 years, has built expertise in mutagenic impurity, E&L, and contamination risk assessments. In recent years, Trish participated in the ICH M7 working group to develop appendix 3 and co-authored the hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation sub-teams and is an active member of the EFPIA working group to support ICHQ3E.

Carla has 20 years of experience in the toxicology field in the pharmaceutical industry in management positions. Experience in safety programs for pharmaceuticals, cosmetics, medical devices, biocides, and other consumer products. She has experience in REACH, toxicological risk assessment, environmental risk assessment, and occupational toxicology. She's the main author or co-author of several papers and posters, published in peer-reviewed journals or presented at international congresses.

Philippe André is a Belgian pharmacist and GMP auditor. He is the director of Qualandre, an auditing company in Hangzhou, China. He lectured in pharmacology at the University of Tianjin between 2006-11. He has since performed about 400 audits of pharmaceutical manufacturers in China, India, and other countries. 

George Johnson is an associate professor of genetic toxicology at Swansea University. He has expertise in the quantitative use of genetic toxicity data for hazard and risk assessment purposes and has an interest in high content and multiplex in-vitro test systems. He currently has active roles in the HESI-GTTC, IWGT 2022, COM and EEMGS-EXCOM, and carries out teaching, research, and consultancy at Swansea.

Mike Urquhart (Ph.D.) has over 20 years’ experience within the Pharmaceutical industry, working mainly in process development as a synthetic organic chemist. Since starting at GSK, Mike has had positions of increasing responsibility ranging from lab chemist and team manager through to chemistry manufacturing and control (CMC) project manager. During his GSK career, Mike has led the primary development/delivery of 10 products, spanning early through to late phase development. Mike’s current roles are co-chair of the Impurities Oversight Panel, where he is a GSK mutagenic impurity risk assessment subject matter expert and Scientific Director as well as the GSK Drug Substance nitrosamine risk assessment lead for small molecules.  Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium and presents externally on best practice for mutagenic impurity control strategies for pharmaceutical products.