pharmacovigilance guidelines

  • Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilence Systems

    • August 27, 2019
    • Posted by: AXSource
    • Category: Blog, Regulatory and Quality
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    Pharmaceutical Companies are using Artificial Intelligence to support their Pharmacovigilence Systems

    Adverse drug reactions (ADRs) refer to unwanted or harmful reactions experienced following the administration of a medication. In Canada alone, the Adverse Drug Reaction Institute has estimated that there are approximately 200,000 severe ADRs each year, though it is believed that 95% of ADRs are not reported to drug manufactures or regulatory agencies such as

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  • What is Pharmacovigilance?

    • July 27, 2019
    • Posted by: AXSource
    • Category: Blog, Regulatory and Quality
    No Comments
    What-is-Pharmacovigilance

    Pharmacovigilance (PV) is defined by the World Health Organization (WHO) as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’. It provides the foundation for monitoring and evaluating adverse drug reactions (ADRs) and is a key component of effective drug regulation, patient safety and

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