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The 11th Impurities: Genotoxic, Nitrosamine & Beyond Summit I #Egenotoxic 2027 is one of the most established and trusted gatherings in pharmaceutical impurity control, bringing together leading experts, regulators, and industry decision-makers. In today’s landscape - where impurity control is a core part of CMC and regulatory strategy - the summit addresses the shift from reactive compliance to predictive, science-driven risk management. With a strong focus on nitrosamines, genotoxic impurities (GTIs), and evolving global expectations, it offers practical, experience-based insights into real regulatory challenges, submissions, and inspection readiness.
Each year, #Egenotoxic reflects the direction the industry is heading - from advanced analytical capabilities and AI-supported toxicological modeling to integrated approaches across formulation, materials, and manufacturing. The 2027 edition will explore emerging nitrosamine risks, NDSRIs, data-driven impurity strategies, and the growing role of extractables and leachables (E&L) in product safety. Taking place on April 7–9, 2027 in Europe (Amsterdam or Basel is considered), it remains a key meeting point for those shaping the future of quality, compliance, and innovation in pharmaceutical development.
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The discovery of nitrosamine contamination, beginning with the valsartan case, fundamentally reshaped pharmaceutical impurity control. What started as a reactive crisis has now evolved into a continuous, lifecycle-driven challenge requiring deep scientific understanding and cross-functional alignment.
Today, nitrosamines - particularly nitrosamine drug substance-related impurities (NDSRIs) - remain a critical focus, driven by:
The industry has moved beyond isolated recalls toward proactive, mechanism-based risk assessment and control strategies.
Regulatory expectations from FDA, EMA, and global authorities continue to intensify, with a clear shift toward:
Updates to ICH M7 (R2) and Q3D frameworks now require companies to embed impurity control directly into CMC strategy, spanning:
Success increasingly depends on cross-functional collaboration between CMC, toxicology, analytical, and regulatory teams - ensuring alignment from development through submission and commercialization.
As the field evolves, impurity control now extends far beyond traditional nitrosamine focus. At #Egenotoxic 2027, key areas include:
The summit reflects a broader reality: impurity control is now a system-level challenge, not a single-discipline task.
The next phase of impurity control is driven by technology and data. Industry leaders are adopting:
These innovations are transforming impurity control from reactive testing into predictive, design-driven decision-making.
Secure your place and position your organization for success in an increasingly complex regulatory landscape.
Participants at #Egenotoxic 2027 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
Register Now - Early Bird by 31st August.
The Early Bird Offer expires in 75 days!
To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.
Register Now - Early Bird by 31st August.
The Early Bird Offer expires in 75 days!
About Speaker
About Speaker
About Speaker
About Speaker
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.
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.
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Apr 21, 2025
9th Impurities: Genotoxic, Nitrosamine, & Beyond Summit | Vienna & Online | April 2025
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