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…
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…
Webinar: ICH Q12 Product Lifecycle Management – open road or dead end?
Next EIPG webinar is to be held on Tuesday 18th April 2023 at 17.00 CEST (16.00 BST) in…
Review of the pharmaceutical legislation, the proposals of the industrial associations
By Giuliana Miglierini The Staff Working Document on “Vulnerabilities of the global supply chains of medicines” published by…
Comments to the draft ICH guidelines Q2(R2) and ICH Q14
by Giuliana Miglierini The public consultation on the two draft guidelines ICH Q2(R2) on the validation of analytical…
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…