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ÚLTIMAS NOTICIAS
New Harmonised Standards under MDR – April 2026
The latest publication of harmonised standards under the Medical Devices Regulation (MDR) – April 2026 is now available. These updates are essential for manufacturers and stakeholders to demonstrate compliance with the MDR, providing presumption of conformity with the...
EMA/CHMP: Updated Guideline on Active Substances published
In March 2026, the now final "Guideline on the chemistry of active substances" was published on the EMA website. As reported in the news "EMA/CHMP: New Guideline Draft on Active Substances published for Comment", the draft guideline was open for public consultation...
Data Quality Framework for EU medicines regulation: application to Real-World Data
EMA released the "Data Quality Framework for EU medicines regulation: application to Real-World Data", establishing the principles and definitions under the scope of datasets used in medicine regulatory use cases. This document describes the Real-World Data...
BOAS PRÁTICAS de FARMACOVIGILÂNCIA : ” Formação completa, contempla os pontos principais de Boas Práticas de Farmacovigilância “
Decorreu nos dias 24 e 25 de março a formação BOAS PRÁTICAS de FARMACOVIGILÂNCIA bajo o lema " Análise do conjunto de regulamentações, documentos e informações que permitem ao titular de AIM avaliar a sua área de farmacovigilância face as exigências regulamentares....
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