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pharmacovigilance

This page shows the latest pharmacovigilance news and features for those working in and with pharma, biotech and healthcare.

FDA rejects Allergan’s uterine fibroid drug over safety concerns

FDA rejects Allergan’s uterine fibroid drug over safety concerns

The findings were backed up by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that Esmya may have contributed to the development of some cases of serious liver injury.

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  • A critical juncture for clinical data management A critical juncture for clinical data management

    The top five most commonly used applications include electronic data capture (EDC) with 100% usage, randomisation and trial-supply management applications with 77% usage, both safety/pharmacovigilance and electronic master file

  • A new era of smart pharma A new era of smart pharma

    A new era of smart pharma. How smarter pharmaceuticals and pharmacovigilance are transforming healthcare. ... SAEs). It is in this area that pharmacovigilance, the science relating to the collection, detection, assessment, monitoring and prevention of

  • Avoiding data pitfalls in clinical research Avoiding data pitfalls in clinical research

    EMA guidance in recent years has touched on the role of genetics in pharmacovigilance and the importance of being able to identify patient populations with increased sensitivity to medicines.

  • AI’s potential in the pharma life cycle AI’s potential in the pharma life cycle

    It has established a pharmacovigilance centre of excellence to collect web and social data for the aforementioned purposes. ... Is head of the pharmacovigilance advisory and medical affairs practice at ProductLife Group.

  • Shoring up the framework Shoring up the framework

    There are personnel aspects to this too if a qualified person for pharmacovigilance lives and works in the UK. ... If a Pharmacovigilance System Master File is located in the UK it will have to be relocated to within the EU/EEA union.

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