A Pharmacovigilance System Master File (PSMF) is one of the most important documents within a pharmacovigilance (PV) system. It provides a comprehensive description of how a company monitors, evaluates, and…

In pharmacovigilance (PV), quality is not just a regulatory expectation; it is the foundation of patient safety. Every adverse event report, safety assessment, and regulatory submission relies on a solid…

The role of pharmacovigilance in patient safety has never been more important. Every day, millions of people rely on medicines to prevent, treat, and manage diseases. While medicines undergo extensive…

Regulatory Affairs and Pharmacovigilance Training has become essential in today’s rapidly evolving pharmaceutical industry. Regulatory requirements continue to change, pharmacovigilance responsibilities are expanding, and regulatory authorities are placing greater emphasis…

In a previous blog post, we shared that the Pharmacy and Poisons Board updated the Guidelines for Establishment of Qualified Persons for Pharmacovigilance (QPPV). Well, since then, the pharmacovigilance environment…