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…
PIC/S Annual Report 2021 by Giuliana Miglierini The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and…
EDQM, the RTEMIS scheme for remote inspections and new application forms for CEPs by Giuliana Miglierini Starting in 2022, the Real-Time Remote Inspections (RTEMIS) programme, established by the European Directorate 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…