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…
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…
Current inspection trends and new approaches to the monitoring of post-inspection activities
by Giuliana Miglierini The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its Annual Regulatory GMP/GDP…
ICMRA published a Reflection paper on remote inspections
by Giuliana Miglierini Remote inspections have become a widely used approach since the last two years to ensure…