A concept paper on the revision of Annex 11 This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP)…
MDCG, a position paper on the capacity of notified bodies by Giuliana Miglierini The lack of a suitable capacity of notified bodies (NBs) is one of the main…
Real-world evidence for regulatory decision-making by Giuliana Miglierini Digitalisation is rapidly advancing also in the regulatory field, as a tool to improve the…
ICMRA, two pilot programmes to optimise regulatory assessment and inspections by Giuliana Miglierini New flexible modalities for the management of regulatory procedures are becoming progressively accepted even for…
The transition towards EMA’s new Digital Application Dataset Integration (DADI) user interface by Giuliana Miglierini The Digital Application Dataset Integration (DADI) network project is aimed to replace the current PDF-based…
Joint implementation plan for the IVDR regulation by Giuliana Miglierini Regulation (EU) 2017/746 (IVDR), establishing the new legislative framework for in vitro diagnostic medical devices…