Andrew Teasdale, PhD till recently was 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 recent role, he was chairing 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 focused on practical implementation of ICH quality guidelines.

Raphael (Raphy) Nudelman is a chemical toxicologist with over 20 years of industry experience. He holds a PhD in organic chemistry from the Weizmann Institute of Science and completed postdoctoral research at the US Air Force Research Lab and Duke University Medical Center. At Teva Pharmaceutical Industries, Raphy held various roles, including in the medicinal chemistry department, the patent department, the non-clinical safety department, and as the Impurity Expert of the company. His expertise spans impurity and excipient qualification in drug substances and drug products, with a recent focus on risk assessment of nitrosamine impurities in pharmaceuticals. Raphy retired from Teva in September 2024 and founded Nudelman ChemTox Consulting, where he continues to provide consulting services in the pharmaceutical impurity qualification field.

Alexander Amberg performed his doctoral studies at the department of toxicology and pharmacology at the University of Wuerzburg (Germany) and obtained his PhD in biochemical toxicology in 2000. In 2001, he joined the early and exploratory safety group of Sanofi, and in this position has been responsible for in silico/computational toxicology analysis globally at Sanofi. Since 2007, he has been registered as a European registered toxicologist (ERT) after getting his examination of Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are development of new in silico prediction models for different toxicity endpoints and data management of in-house data in combination with publicly available toxicity data, to support drug development in research and development. For this he is also a member of different internal expert advisory groups as well as external initiatives, like the IMI eTOX consortium (for toxicity data sharing and development of new expert systems for in silico toxicity prediction), the IMI SafeSciMET education program and others. With respect to genotoxic impurities (GTIs), he was actively involved in the preparation of the white paper for the use of in silico systems in the scope of ICH M7 and other publications regarding GTIs. Internally, he is member of the task force to support the in-house implementation of ICH M7.

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.

Olivier Dirat is Senior Director within Pfizer Global Regulatory Sciences CMC Advisory Office where he provides technical and regulatory guidance on a wide array of topics, including CMC regulatory strategies, the development and articulation of control strategies, impurities management, nitrosamines, continuous manufacturing, starting materials, ADCs, mRNA vaccine lipids and other special cases. External to Pfizer, Olivier is involved with ICH as co-rapporteur for ICH Q6 EWG (PhRMA) and was deputy topic lead for ICH Q13 IWG (PhRMA), IQ consortium Board of Directors and various working groups including Nitrosamines and EFPIA for CMC topics including Nitrosamines, ICH M7, and ICH Q6. He has co-authored over 40 publications and is a regular conference speaker. Olivier is based in Sandwich, UK.

Dr Sylvia E. Escher, is a chemist by training and joined the Fraunhofer Institute of Toxicology and Experimental Medicine (ITEM) in Hanover, Germany in 2006. She currently leads the division “Safety Assessment and Toxicology” and the department “In Silico Toxicology”. Her main expertise is human risk assessment. Her interests include the development and maintenance of toxicological databases such as RepDose, and their use to develop and improve human risk assessment methods. Examples include the development of NAM supported read-across approaches and the TTC concept. Her team is currently contributing to i) the development of structure activity relationships of Nitrosamines, ii) the development of adverse outcome pathways (AOPs) for pulmonary fibrosis and to a PBK model addressing in particular the integration of in vitro ADME properties of airborne compounds. She currently coordinates several MUTAMIND projects, which evaluate differences in mutagenic activity of NDSRIs.

Dr. Ulrich Reichert, M.D.R.A., is Head of CDMO and Bioprocess Materials, Regulatory Management, Life Science at Merck KGaA, Darmstadt, Germany. He leads a global team providing regulatory support for contract manufacturing of active substances, biologics, mRNA, viral vectors, monoclonal antibodies, and recombinant proteins, including regulatory site registration of manufacturing sites worldwide.

Previously, he led the organization “Pharma and Food Materials,” a global team responsible for product and site registration worldwide, such as registration of APIs and excipients (CEP, ASMF, US-DMF, Japan-DMF, China Co review), as well as the implementation and maintenance of regulatory requirements for materials used in drug production. With more than 25 years of regulatory and quality experience for materials for active substances of both chemical and biological origin, he brings extensive expertise to his current role.

Dr. Reichert is a pharmacist with a PhD (Dr. rer. nat.) in Medicinal Chemistry from the University of Berlin and a Master of Drug Regulatory Affairs (M.D.R.A.) from the University of Bonn. He contributes actively to international regulatory and scientific bodies: he is a member of the ICH-M7 subgroup on nitrosamine impurities, serves as a member of two expert groups of the European Pharmacopoeia (EDQM), and is a member of the pharmacopoeia committee on medicinal chemistry at BfArM (the German Health Authority). In addition, he chairs the IPEC Europe Nitrosamine Task Force and is a member of its Quality and Regulatory Affairs Committee, serves on the APIC Nitrosamine Task Force, and is also a member of the Deutscher Arzneimittel Codex (DAC) Commission.

Rok Grahek received his BSc in chemistry and his PhD in science from the University of Ljubljana, Slovenia.

In 1986, Rok was employed in R&D in Lek Pharmaceuticals d.d. Slovenia.

As a researcher he started with GC and after a few years HPLC and MS became his main area of interest in connection with impurities in drugs. Trace analysis of impurities (genotoxic impurities, synthetic tracers, nitrosamines) with LC-MS and GC-MS is an important area of Rok’s research. For the past 25 years, Rok has been leading a group or researchers dealing mainly with impurity profiles, impurities isolation, identification, and trace analytics.

Rok is an author or co-author of nearly 40 patents and scientific papers and more than 50 scientific conference contributions.

As a seasoned human and environmental toxicologist, Dr. Frank Liu has more than 14 years’ hands-on work experience and significant publication record in chemical risk assessment, genotoxicity, and general toxicology. After his master and Ph.D. education in environmental toxicology and two postdoctoral trainings in pharmaceutical sciences and human toxicology, Dr. Liu moved to product safety assessment area in the pharmaceutical and personal care product industries. When it comes to drug safety, his major responsibilities include safety assessment of process- and modality-related drug impurities and contaminants such as extractables, leachables, intermediates, catalysts, particulate matters, elemental, and solvent impurities as well as manufacture incidence-related impurities via traditional (i.e., animal data-based) risk assessment and new approach methodologies (NAM)(i.e., in chemico, in silico, and in vitro)-based next generation risk assessment (NGRA) as well as environmental and occupational safety assessment.

Dr. Paulo Eliandro da Silva Junior is a Pharmacist-Biochemist (USP) with a Master’s and PhD in Medicinal Chemistry, Synthesis, and Drug Discovery (FCFRP-USP, University of East Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). He began his career in the pharmaceutical industry in 2013 as a trainee at Novartis, Horsham, UK, in the Global Discovery Chemistry department. Since then, he has worked mainly in regulatory affairs with a focus on Drug Master Files (DMF), quality audits, mutagenic impurities, purge factor calculations, and nitrosamine control. He is the founder of Integra Consultancy and BIND, a company dedicated to the synthesis and characterization of analytical standards, including degradation products and nitrosamines.

Mayur Mitra is an American board-certified toxicologist and currently serves as a Distinguished Scientist - Toxicologist within Safety Assessment at Genentech Inc. As part of his role he serves as the Therapy Area Lead for Genentech’s Oncology portfolio and as a Cross-functional Drug Development Team Lead. Previously, Mayur was employed as a Toxicologist at Bristol-Myers Squibb. Mayur received a PhD in Toxicology from the University of Louisiana at Monroe and a postdoctoral fellowship at the Washington University School of Medicine in St. Louis. Mayur is well published and has authored 25+ peer reviewed articles and book chapters.