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…
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…
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…
Real-world evidence for regulatory decision-making
by Giuliana Miglierini Digitalisation is rapidly advancing also in the regulatory field, as a tool to improve the…
ICMRA, two pilot programmes to optimise regulatory assessment and inspections
by Giuliana Miglierini New flexible modalities for the management of regulatory procedures are becoming progressively accepted even for…
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,…