Do 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.
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Can 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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Medical device labelling is more than just a regulatory requirement—it’s a critical communication tool that ensures safety, usability, and compliance. Whether you’re a manufacturer, distributor, or healthcare provider, understanding the essential elements of clear and
Read MoreIn an era where real-world data (RWD) is reshaping pharmacovigilance, the ability to detect and manage safety signals effectively has become a cornerstone of regulatory compliance and patient protection. With data flowing from electronic health
Read MoreIn today’s rapidly evolving pharmaceutical landscape, regulatory authorities around the world place increasing emphasis on drug safety. As a result, Qualified Person for Pharmacovigilance (QPPV) services have become a critical component of global pharmacovigilance systems.
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