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The 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit I #Egenotoxic 2026 is one of the most respected and widely attended gatherings in the field of pharmaceutical impurity control. Trusted by leading experts, regulators, and innovators across the industry, this renowned event is where the global pharma community comes together to tackle the most pressing challenges around nitrosamines, genotoxic impurities (GTIs), and regulatory compliance. Known for its depth, clarity, and practical takeaways, the summit sets the standard for excellence in ICH M7 and Q3D implementation, risk assessment, and analytical science.
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The Valsartan recall due to N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) contamination marked a turning point in pharmaceutical impurity control. This crisis emphasized the urgent need for:
Subsequent regulatory actions and recalls involving drugs like ranitidine, metformin, and varenicline have spotlighted the ongoing challenges in managing nitrosamines across the pharmaceutical supply chain.
Heightened scrutiny from the FDA, EMA, and other agencies has driven updates to:
Industry stakeholders must integrate nitrosamine risk assessments into:
Collaboration among pharmaceutical manufacturers, excipient suppliers, toxicologists, and regulators is essential to develop effective control strategies and address knowledge gaps.
At #Egenotoxic 2026, the conversation broadens to include:
The summit will cover:
This will help attendees navigate complex impurity profiles and optimize quality control processes.
Secure your spot today and ensure you’re equipped to navigate the rapidly evolving pharmaceutical impurity landscape.
Participants at #Egenotoxic 2026 will receive a digital certificate of attendance.
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specializing in:
Pharmaceutical Development & Chemistry
Analytical & Laboratory Sciences
Impurities & Toxicology
Quality, Compliance & Regulatory
Emerging Technologies & Topics
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To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
First Early Bird tickets available
The Early Bird Offer expires in 46 days!
About Speaker
About Speaker
About Speaker
About Speaker
About Speaker
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.
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