Date:
June 8 - 9, 2026
Day1:
Mon, Jun 08 8:30 a.m. - 04:30 p.m. ET
Day2:
Tue, Jun 09 8:30 a.m. - 04:30 p.m. ET
The workshop will be held as a hybrid (in-person and virtual) meeting.
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The prominence of nitrosamines in this workshop really speaks to the challenge that the subject still poses.
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I am planning to be there in-person! anybody else plan to be there?
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This assortment of various topics on nitrosamines, presented every 10 minutes, is as fascinating as a toy box.
There will be a lot of good discussion. It also shows how important this topic is. AAM (Association of Accessible Medicines) will have some good presentations from its member companies. While I will be travelling internationally and not be able to attend, I think it woud be a great forum to attend, even for innovator companies, since nitrosamines do not understand the difference between generics and innovators and attack them equally 
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Hola, Âżdonde se impartira este taller?, me interesa saber los costos y la sede. Muchas gracias!
Malice, este taller es gratuito.. todas las presentaciones y materiales estarán disponibles después del evento.
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Now, recordings and materials are available.
Recordings
Session 1: Ongoing Challenges with Nitrosamines Impurities
Part1
Part2
Materials
Nitrosamines in Drugs: A Regulatory Perspective on Research Progress and Opportunities
Overview of HESI Program and Research Initiatives
Using In Vivo Transgenic Rodent (TGR) Data to Evaluate Mutagenic Potency
Nitrosamine Mitigation Strategies: Insights from the FDA and Emerging Challenges
Antioxidants in Nitrosamine Risk Mitigation: Challenges and Considerations
Cracking the NDSRI Code: Mitigation in Generic Drugs, a Mission impossible?
Analytical Methods for NDSRIs: Challenges & Troubleshooting
Nitrosamine Risk of Recovered Solvents & NOx as Nitrosating Agent
The Role of Excipients in Nitrosamine Risk Mitigation: Nitrite Control and Scavengers
Using In Vivo Mutation Data for Risk Assessment of Nitrosamine Impurities
VICT3R Virtual Control Groups. Towards Qualification and Regulatory Acceptance
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