EMA’s recommendations to prevent medicines shortages
By Giuliana Miglierini Continuity of medicinal product supply is still representing a key issue for European countries. The…
EDQM introduces a consultation phase in the management of CEP documents
by Giuliana Miglierini The new process implemented by the European Directorate for the Quality of Medicines and HealthCare…
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…
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…
Revision of the CDMh’s Q&As document on nitrosamine impurities
by Giuliana Miglierini The review process of medicinal products started in 2018 to assess the presence of nitrosamine…