EMA/EFSA joint report on human dietary exposure to residues of veterinary medicines, pesticides and feed additives
By Giuliana Miglierini The presence of residues of veterinary medicines, feed additives and pesticides in food of animal…
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…
A concept paper on the revision of Annex 11
This concept paper addresses the need to update Annex 11, Computerised Systems, of the Good Manufacturing Practice (GMP)…
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…