The pharmaceutical industry is witnessing a transformative shift as artificial intelligence (AI) becomes increasingly integrated into drug safety monitoring and pharmacovigilance (PV) processes. In 2024 and early 2025, major regulatory bodies including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the International Council for Harmonisation (ICH) have released comprehensive guidelines […]
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The pharmaceutical industry is undergoing a fundamental transformation where traditional boundaries between clinical development and post-market pharmacovigilance are dissolving. As regulatory expectations evolve and patient safety remains paramount, integrating clinical and pharmacovigilance (PV) systems has become a strategic imperative for organizations seeking to optimize drug safety throughout the product lifecycle. This integrated approach shifts from […]
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The pharmaceutical industry sits at a crossroads of innovation and responsibility. While companies race to develop life-saving treatments, they must simultaneously ensure these medications remain safe for millions of patients worldwide. Enter pharmacovigilance — the science of monitoring drug safety throughout a medication’s lifecycle. Today, artificial intelligence is revolutionizing this critical field. From processing thousands […]
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Efficient and compliant case intake is the backbone of modern pharmacovigilance. As the pharmaceutical industry faces escalating data volumes, complex global regulations, and mounting cost pressures, automation of case intake is emerging as a strategic imperative. This guide examines the tools, processes, challenges, and return on investment (ROI) associated with automating pharmacovigilance case intake—equipping pharmaceutical […]
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The pharmaceutical industry stands at a pivotal moment in drug safety monitoring. As we advance through 2025, artificial intelligence is fundamentally transforming how we detect, analyze, and respond to adverse drug reactions. For pharmaceutical professionals, understanding this shift from traditional pharmacovigilance methods to AI-powered systems isn’t just beneficial—it’s essential for staying competitive and ensuring patient […]
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Every day, millions of people around the world take different medicines. With thousands of medications out there, how do healthcare professionals keep track of them all? How do they know which medicines are similar, or might cause the same side effects? This is where WHO Drug SDGs come in. WHO Drug SDGs refer to the WHO Drug […]
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Avoiding the Pitfalls of Misapplied AI to Protect Patient Safety and Ensure Compliance The hyperactivity around AI today feels like a modern gold rush, with every industry racing to stake its claim. Not a single day passes without the news of the impact (positive or negative) that AI is going to have in every aspect […]
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Artificial intelligence (AI) is transforming industries, and pharmacovigilance is no exception. But let’s face it: navigating the world of AI solutions for pharmacovigilance can feel like trying to solve a puzzle with too many pieces. From streamlining case management to enhancing signal detection and risk evaluation, AI has the potential to revolutionize drug safety processes. […]
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