EIPG Training Course: Annex 1
Dear colleagues, I am very pleased to announce the GMP/Annex 1 Professional Training Course which will be held…
Swissmedic’s technical interpretation of Annex 1
by Giuliana Miglierini New insights on the interpretation of the new Annex 1 to Good manufacturing practices (GMPs)…
EMA’s new Quality Innovation Expert Group (QIG)
by Giuliana Miglierini Innovative approaches to the development manufacturing and quality control of medicines are becoming the new…
MDCG, a position paper on the capacity of notified bodies
by Giuliana Miglierini The lack of a suitable capacity of notified bodies (NBs) is one of the main…
ACT EU’s Workplan 2022-2026
by Giuliana Miglierini The implementation phase of the Accelerating Clinical Trials in the EU (ACT EU) initiative, launched…
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,…