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.

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.

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.

Elisabeth is Head of Unit Quality Assessment for chemical Medicinal Products and IMPs at the Austrian National Competent Authority and holds a PhD in Pharmaceutical Chemistry. She is a regulatory professional with extensive expertise in pharmaceutical quality and regulatory frameworks.

In addition to her role at AGES, she actively contributes to international regulatory activities and serves as a European expert at the European Medicines Agency (EMA), where she is involved in all types of procedures, contributes to the drafting and revision of guidance documents (including the LALA cutaneous guideline), and provides training within the QWP curriculum for quality assessors. She is a member of EMA’s Combination Products Operational Group (COMBO).

In addition, she is an assessor for the chemical purity and microbiological quality evaluation within the EDQM certification procedure.

As a member of the ICH Q6(R1) Expert Working Group, representing the European Commission, Elisabeth leads the subgroup responsible for the chemical section.

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 Sanofi and is since that time 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 the Fachtoxikologe DGPT from the German Society of Toxicology. His major research interests are data management and digitalization of preclinical and clinical safety data and development of new in silico prediction systems for different toxicity endpoints from these 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 eTRANSAFE consortium (for translational safety assessment and development of new in silico prediction systems), the VICT3R consortium (for replacing of control animals in a toxicity study by virtual control data) and with respect to genotoxic impurities and nitrosamine actively involved in different cross-company collaborations. With this expertise he is author of more than 60 publications in scientific literature.