The 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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Germany is Europe’s largest pharma market with strict regulations. Learn how Vigilare helps companies navigate BfArM, EMA, and EU compliance with speed and clarity.
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Introduction In today’s highly regulated pharmaceutical environment, a company’s pharmacovigilance system defines its credibility, transparency, and commitment to patient safety. At the heart of this system lies the Pharmacovigilance System Master File (PSMF) — a
Read More🌐 Introduction The clinical research landscape is evolving rapidly. Traditional site-based trials, while foundational, often face limitations in patient recruitment, retention, and geographic reach. Decentralised Clinical Trials (DCTs) are emerging as a transformative model —
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