Devido ao alerta , e de forma a garantir a segurança de todos os participantes , as sessões de formação agendadas para os dias 11 e 12 de novembro , serão reagendadas para os dias 18 e 19 de novembro
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Clinical evidence for orphan in vitro diagnostic medical devices
This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The...
Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
The European Medicines Agency (EMA) has released Revision 24 of its nitrosamine Q&A, introducing several important updates: https://lnkd.in/gAvk967S
TEAM NB Code of Conduct for Notified Bodies vs 5.3
Team-NB members adopted, at the unanimity of the presents, an updated version od the Code of conduct including a new paragraph requiring notified bodies to have a QMS process to investigate suspected certificate falsification or misuse, preserve evidence, take...
GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
As the European Union prepares to revise its Good Distribution Practice (GDP) Guidelines, GIRP, the European Healthcare Distribution Association, launches today its front-running position paper setting out key priorities of the sector.GIRP suggests that the new GDP...
Comprometidos com a qualidade e a inovação.
