Artificial intelligence (AI) is rapidly transforming the way safety monitoring is conducted in healthcare. Nowhere is this transformation more visible than in pharmacovigilance (PV), where the traditional model rooted in spontaneous reporting systems and manual case processing is being reshaped by automation, advanced analytics, and real-world data (RWD). But this evolution goes beyond drugs. It… Continue reading From Pharmacovigilance to Multivigilance: How AI and RWD Are Redefining Safety Surveillance in Healthcare
Category: Drug Safety
Conducting Post-Authorization Safety Studies (PASS) in Italy: Regulatory and Best Practice Considerations
Post-Authorization Safety Studies (PASS) are vital tools for monitoring the safety of medicines after they have been approved for use in the general population. In the European Union (EU), these studies are conducted within the framework established by the European Medicines Agency (EMA). However, when conducting a PASS under the EMA framework, there might be… Continue reading Conducting Post-Authorization Safety Studies (PASS) in Italy: Regulatory and Best Practice Considerations