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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...
New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
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 guidance is...
AI in pharmacovigilance – EMA update
Industry Stakeholder Platform Operation of EU Pharmacovigilance 20 October 2026 Luis Pinheiro (Data Analytics and Methods Task Force) Julie Durand (Pharmacovigilance Office)
Comprometidos com a qualidade e a inovação.
