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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.

Latest news

  • Some pharma companies not prepared for Brexit, warns EMA Some pharma companies not prepared for Brexit, warns EMA

    change of the qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) to a location in the EEA.

  • MHRA suspends new prescriptions of fibroid drug Esmya MHRA suspends new prescriptions of fibroid drug Esmya

    In December, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of the treatment for abnormal bleeding in women with uterine fibroids after four cases of serious liver injury -

  • Through the Looking Glass Through the Looking Glass

    A concept known as pharmacovigilance. What does that mean? It means that when someone gets on their Facebook account and reports that they are feeling ‘sick’ after taking their medicine or

  • Sanofi launches French eHealth laboratory 39BIS Sanofi launches French eHealth laboratory 39BIS

    Sanofi’s eHealth strategy in France is focused on healthcare professionals - including dispensing pharmacists - and medicines, pharmacovigilance, skin disorder diagnosis and exploring diagnostics in rare diseases and vaccines.

  • MHRA joins Instagram as part of Yellow Card drive MHRA joins Instagram as part of Yellow Card drive

    The MHRA’s social media campaign, of which its new Instagram account is just one element, is part of Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE), a joint action project

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Latest Intelligence

  • Five questions guiding the way to actual patient-centricity Five questions guiding the way to actual patient-centricity

    We worry about the effort real patients might make, the risks of social media, pharmacovigilance, off-label questions and a minefield of legal requirements. ... In the right environment, their influence is most notable, and third-party providers can

  • 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

    How smarter pharmaceuticals and pharmacovigilance are transforming healthcare. The pharmaceutical industry is undergoing an evolution as new technologies disrupt the industry. ... SAEs). It is in this area that pharmacovigilance, the science relating to

  • 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.

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