EMA’s 3-year work plan for the Quality domain
by Giuliana Miglierini The European Medicines Agency has released the input notes made by the GMDP Inspectors Working…
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…
ICMRA published a Reflection paper on remote inspections
by Giuliana Miglierini Remote inspections have become a widely used approach since the last two years to ensure…