A lot of things have happened at Asphalion during these past three months, and we have summarized the highlights in a two minutes video. You can watch it HERE:
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The World Drug Safety Congress offers the perfect setting to address how to drive pharmacovigilance operations forward for industry professionals, international regulatory bodies and academic representatives.
Este artículo aborda la innovación en el campo de la Farmacovigilancia (FV) mediante la implementación de técnicas avanzadas de automatización y aprendizaje automático en las búsquedas bibliográficas, un proceso crucial para garantizar la seguridad de los medicamentos.
This guidance recommends steps manufacturers and applicants of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in drug products. The guidance also describes conditions that may introduce nitrosamine impurities. The unexpected finding of nitrosamine impurities, which are probable or possible human carcinogens, in certain drug products has made clear the need for a risk assessment strategy for the potential presence of nitrosamines in any drug product.
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