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…
EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…
Revision of the PIC/S GMP Guide: Annex 13 and Annex 16
by Giuliana Miglierini The entry into force of EU Regulation 536/2014 “Clinical trials”, at the end of January,…
The new Annex 21 to GMPs
by Giuliana Miglierini The new Annex 21 to GMPs (C(2022) 843 final) that EIPG gave a significant contribution…
The new PIC/S guideline on data integrity
by Giuliana Miglierini The long waited new PIC/S guideline PI 041-1 has been finally released on July 1st;…