The current status of the transition to the MDR and IVDR regulations
by Giuliana Miglierini As the term to apply for the certification of medical devices and in vitro diagnostics…
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…
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…
FAT and SAT, a critical step for the introduction of new equipment
by Giuliana Miglierini There are two key moments to be faced to introduce a new piece of equipment…
Steps towards the final approval of the IP action plan
By Giuliana Miglierini The end of 2021 may see the final approval of many pieces of the new…