A study on the reprocessing and reusing of single-use devices
by Giuliana Miglierini Reprocessing and reusing are one of the key actions central to many new EU policies…
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…
The European Medicines Regulatory Network Data Standardisation Strategy
by Giuliana Miglierini The availability of interoperable data is a “must” to ensure the smooth sharing, use and…
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…
Consultation open on the ICH Q13 guideline on continuous manufacturing
by Giuliana Miglierini The new ICH Q13 guideline on the continuous manufacturing of drug substances and drug products…