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 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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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
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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
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In 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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Is your clinical trial ready for ICH E6 (R3)? Discover the key areas to focus on, from risk-based quality management to digital transformation, and ensure compliance with the latest GCP guidelines.
Read MoreSeveral Emerging trends are shaping the Pharmacovigilance and Regulatory Affairs domains in 2025 making their collaboration even more critical: 1. Integration of Artificial Intelligence (AI) and Machine Learning (ML) AI and ML are revolutionizing both
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