Globally, Pharmacovigilance (PV) is built on one central idea: the benefit–risk evaluation should not stop at approval; it must continue through the full drug development regulatory process and the product’s commercial lifecycle. It is no
Read MoreDespite being an established practice in the pharmaceutical industry, the question ‘What is Pharmacovigilance?’ remains a frequently asked one among the general public, students, and healthcare professionals, including doctors and nurses, in developing regions. Whether
Read MoreWhy PV Mandates Matter in 2026? Pharma manufacturers are rapidly launching their products across borders, directly intensifying the burden on safety monitoring. On the other hand, to enable quick signal detection, the PV processes are
Read MoreDo you know? As per the EU Regulation 2025/1466 and evolving signal-monitoring expectations, accountability of the Qualified Person Responsible for Pharmacovigilance (QPPV) towards EudraVigilance monitoring, PSMF data accuracy, audit-readiness, etc., is becoming significant and mandatory.
Read MoreCan AI Replace Signal Detection? The simple answer we have is, not yet, and not entirely. For sure, Artificial Intelligence (AI) is, or will be, capable of rapid scanning of humongous Pharmacovigilance databases, including FAERS,
Read MorePharmacovigilance (PV) Regulation (EU) 2025/1466 is not just an annotation to Regulation (EU) 520/2012. It is a key arrangement for MAHs to understand how seriously they should work on safety systems (design, contract, audit, and
Read MoreDo you have authorization to conduct a clinical trial with your investigational drug? Do you know that you should evaluate the safety data and analyse the emerging risks during trials? During the clinical development of
Read MoreThe pharmacovigilance (PV) landscape is evolving rapidly, triggered by increasing data volumes, global collaborative efforts, and demanding data transparency expectations. Given the scenario, 2026 is expected to become a defining year for the Pharmaceutical industry
Read MoreFDA Pharmacovigilance Status Quo: Do you know? The Food and Drug Administration’s (FDA’s) Adverse Event Reporting System (FAERS) contains 25 million adverse event reports in its database. The Agency processes more than 2 million ADRs
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Pharmacovigilance 2026 is set to be a definitive platform for patient safety, featuring strengthened and automated vigilance systems. The future of Pharmacovigilance is poised for a transformative shift, driven by new avenues such as automation
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