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10th Impurities: Genotoxic, Nitrosamine & Beyond Summit

10th Impurities: Genotoxic, Nitrosamine & Beyond Summit
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Date4th – 5th Mar 2026
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PlaceMilan & Online, Italy
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VenueStarhotels Grand Milan

Global Experts Gather in Milan for the 10th Impurities: Genotoxic, Nitrosamine & Beyond Summit (#Egenotoxic 2026)

Milan, Italy – March 2026 — The #Egenotoxic 2026 brought together over 100 pharmaceutical experts from around the world on March 4–5, 2026, in Milan and online. The event provided a key platform for discussing current challenges and solutions in the management of pharmaceutical impurities.

Triggered by major industry events such as the Valsartan recall due to nitrosamine contamination, regulatory scrutiny around impurities has significantly increased. At the summit, experts addressed evolving regulatory expectations, including updates to ICH M7 and Q3D guidelines, as well as strategies for managing nitrosamines, genotoxic impurities, elemental impurities, and extractables and leachables (E&L).

Through scientific presentations and discussions, participants explored advanced analytical technologies, risk assessment approaches, and new industry data, helping organizations strengthen pharmaceutical quality control and ensure patient safety.

Special thanks go to moderators Andy Teasdale and Paulo Eliandro for guiding the discussions and ensuring a dynamic exchange of knowledge. The organizers also extend their sincere appreciation to all speakers, sponsors, and partners whose contributions made the summit possible.

As regulatory expectations continue to evolve, #Egenotoxic remains an important international forum for collaboration and knowledge sharing in pharmaceutical impurity management.

Speakers

Dr. Andrew Teasdale, UK
Dr. Andrew Teasdale, UKDirector (Former Head of Impurity Management & CMC Strategy at AstraZeneca)AT CMC Solutions Limited
Dr. Raphael Nudelman, IL
Dr. Raphael Nudelman, ILConsultantNudelman ChemTox Consulting
Dr. Olivier Dirat, UK
Dr. Olivier Dirat, UKSenior Director, Global Regulatory Sciences CMC Advisory OfficePfizer
Dr. Alexander Amberg, DE
Dr. Alexander Amberg, DEGlobal In Silico Toxicology Analysis I R&D Preclinical SafetySanofi
Dr. Saroj Pau, IN
Dr. Saroj Pau, INAssociate Director, Analytical R&DNovartis

Sponsors

Resolian
MEGGLE Excipients
Aptar CSP Technologies
Nelson Labs
SGS
Lhasa Limited
QualiMetrix S.A.
Innovatune
GBA PHARMA GmbH

Industry about the event

Alex from null
AlexAssoc Director, API

I was impressed with how well I was able to follow the conference as a virtual attendee. I liked that there was always a camera on the speaker and that it appeared to be manually operated- following them and also turning into the audience for questions.

Eleni from null
Eleni

Wow! What a blast 🚀 Each year this summit grows bigger, more dynamic, and even more inspiring. Thank you to the outstanding scientists and speakers who shared their knowledge and vision, to all the colleagues who exchanged ideas, sparked meaningful discussions, and made time in Milan truly unforgettable, and last but not least, to the organizers Etapa Pharma for delivering such a well-executed and impactful summit 👏 A special thank you to Rontis Hellas Rontis Corporation for the unwavering support 🙏 . Already looking forward to what next year will bring! ✨

For any event assistance please contact

Gabriela Rychtářová
Gabriela RychtářováSales & Marketing Manager