The first revision of the ERA guideline on environmental risk assessment
by Giuliana Miglierini It took eight years before revision 1 of the EMA guideline on environmental risk assessment…
How to approach drug substance supply in new product introduction (NPI) processes
by Giuliana Miglierini A key issue to be faced during pharmaceutical development refers to the supply of the…
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,…