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…
EMA’s reflection paper on single-arm clinical trials
by Giuliana Miglierini Single-arm clinical trials (SATs) are often the preferred study design in cases where target populations…
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…