Navegar por el torbellino que rodea a las impurezas de las N-nitrosaminas en los principios activos y los medicamentos
Octubre 1, 2025
El líder del Grupo de Prácticas de la FDA, David Rosen, intervendrá en el Taller de Otoño de SAAMnow en la sesión "Navigating the Whirlwind Surrounding N-Nitrosamine Impurities in APIs and Drug Products" el 1 de octubre.
The workshop will focus on regulatory, scientific, and technical challenges surrounding the presence of N-nitrosamine impurities in active pharmaceutical ingredients (APIs) and drug products. Participants will explore cutting-edge methods, regulatory updates, and research developments regarding N-nitrosamines.
The workshop will address:
- U.S. Food and Drug Administration (FDA) perspective on N-Nitrosamine Impurities,
- International Generic and Biosimilar Medicines Association (IGBA) perspective on nitrosamine impurities, the worldwide challenges,
- ICH M7 risk assessment and control of N-nitrosamine impurities,
- Over-the counter (OTC) drug products and their challenges with N-nitrosamine impurities, and
- Prescription drug products and their challenges with N-Nitrosamine impurities.
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