The ICMRA collaborative hybrid inspection pilot (CHIP)
by Giuliana Miglierini Hybrid inspections emerged during the pandemic as a new way to approach the assessment of…
The first Union list of critical medicines
by Giuliana Miglierini The first version of the Union list of critical medicines was published on 12 December…
Swissmedic’s technical interpretation of Annex 1
by Giuliana Miglierini New insights on the interpretation of the new Annex 1 to Good manufacturing practices (GMPs)…
The current status of the transition to the MDR and IVDR regulations
by Giuliana Miglierini As the term to apply for the certification of medical devices and in vitro diagnostics…
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…