EMA’s reflection paper on AI in the pharmaceutical lifecycle
by Giuliana Miglierini The rapidly evolving role of artificial intelligence (AI) and its possible application in the pharmaceutical…
The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment
by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company…
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 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;…