In Europe, Pharmacovigilance is heavily dependent on submitted documents. Each core submission enables regulators to assess how data has been maintained throughout the product life cycle. This approach minimizes risks. A robust safety system can
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 MoreStepping into 2026, the challenge for marketing authorization holders (MAHs) is not only to address AI intrusion into pharmacovigilance but also to ensure their existing pharmacovigilance systems are compliant, all-through, controlled, data-driven, and inspection-ready for
Read MoreThe European Medicines Agency (EMA) is re-examining its approach to drug safety. The 2026 pharmacovigilance (PV) framework marks significant progress in using real-world evidence (RWE) to monitor medicines and inform regulatory decisions in the European
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
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In India, a crisis happened in late 2025 with respect to a cough syrup, which led to fatal cases of many children, and in no time, the news spread across and encouraged swift action, including
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
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