Genotoxic and Elemental Impurities LIVE webinar will provide practical regulatory, toxicology, analytical considerations on:
Join us virtually, learn and exchange a recent practical experience on the subject. The brochure contains additional information and key insights of the LIVE webinar.Read more
Genotoxic and Elemental Impurities LIVE webinar on 3 June 2020 will be hosted by the leading subject matter experts, providing an opportunity to participate in the interactive discussion on the recent strategies and perspectives in the respective field and to engage in comprehensive informative presentations / technical training.
Join us virtually, learn, and exchange recent practical experience on:
- practical regulatory, toxicology, analytical considerations on efficient mutagenic and elemental impurity identification, monitoring, and control
- critical issues and best practices on quality, safety, and efficacy of drug products
- expectations on regulatory submissions
A digital certificate of attendance will be available for participants.
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:
Chemistry (Analytical, Organic, Medicinal, Protein)
Extractables & Leachables (E&L)
Genotoxic Impurities (GTIs)
Good Manufacturing Practices (GMP)
Good Laboratory Practice (GLP)
Permitted Daily Exposure (PDEs)
Quality by Design (QbD)
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 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, extractable and leachable, 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 and 2011. He has since performed about 400 audits of pharmaceutical manufacturers in China, India, and other countries.
Dr. George Johnson is an associate professor at the Institute of Life Science at Swansea University, UK. In 2006, George obtained his Ph.D. degree in Swansea, under the supervision of Professor Jim Parry, and since then he has developed a great interest in the statistical approaches and underlying mechanisms that support points of departure (PoD) for Swansea University genetic toxicity. This expertise has led George to be a steering member of the Health and Environmental Science Institute (HESI) and the Genetic Toxicology Technical Committee (GTTC), as well as being co-chair of the GTTC quantitative workgroup. His work includes improving the quantitative use of genetic toxicity data for human-health risk-assessment (Johnson et al., 2014, EMM), and he links this to his great interest in replacing, reducing and refining (3Rs) the use of animals in research.
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 GSK CMC due diligence lead for small molecules and co-chair of the Genotoxic Risk Assessment (GRA) review team, where he is GSK subject matter expert. Mike also represents GSK on the Lhasa Mirabilis Pharmaceutical Consortium.
The Genotoxic and Elemental Impurities Live Event Recording is available.
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“It is a great opportunity to connect with colleagues, share our experience and process with and learn from our colleagues about their experience and process.”
Head of Product Characterization and Risk Assessment (PCARA) / Drug Safety Research and Evaluation (DSRE), R&D at Takeda
“I absolutely enjoyed the meeting with such a focused topic.”
Director, Global Pre-clinical Development at Abbott Laboratories
“Thanks a lot for all your organization which made this summit a real success.”
E&L Laboratory Manager at Eurofins Biopharma Product Testing Italy
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