EMA’s 3-year work plan for the Quality domain by Giuliana Miglierini The European Medicines Agency has released the input notes made by the GMDP Inspectors Working…
The new MHRA’s framework for clinical studies By Giuliana Miglierini The repositioning of the United Kingdom as a global leader for clinical development of medicinal…
PIC/S new guidance documents for GDP inspectors By Giuliana Miglierini Two new guidance documents for GDP inspectors have been issued by the Pharmaceutical Inspection Cooperation…
Draft ICH M13A guideline on bioequivalence open for consultation By Giuliana Miglierini The draft ICH M13A harmonised guideline “Bioequivalence for immediate-release solid oral dosage forms” was endorsed…
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…