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EMA

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

AstraZeneca joins Merck in Brexit stockpiling effort

AstraZeneca joins Merck in Brexit stockpiling effort

The European Medicines Agency (EMA) earlier this month warned that many pharma manufacturers were not ready for Brexit and there was a risk of supply shortages for some medicines if action ... MPs also voted that the government must make the UK remaining

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  • Protecting patient privacy Protecting patient privacy

    is left to chance. Stay focused. Undoubtedly, the demands of EMA Policy 0070 are considerable. ... is EMA policy 0070 regulation and compliance expert at Kinapse. 3rd June 2018.

  • The NHS and ABPI at 70: inching closer to the triple win The NHS and ABPI at 70: inching closer to the triple win

    Mike Thompson told a Parliamentary committee last year he could see no upsides to Brexit: losing EMA membership, EU research funding and diminished access to scientific talent, and relegation as a

  • Uncertainty, austerity and Brexit Uncertainty, austerity and Brexit

    or where clinical trials are placed. Recognising the potentially negative consequences, the UK Government has moved away from its hard-line position on the EMA and now seems keen to remain

  • Brexit Means Brexit Brexit Means Brexit

    The Prime Minister specifically cited the importance of regulatory alignment for the pharmaceutical industry, indicating a determination to explore how the UK can remain a member of the EMA. ... At the headline level it seems the EMA is encouraging

  • Deal Watch January 2018

    Ablynx submitted its MAA to the EMA for approval of caplacizumab in February last year and, according to Reuters, Ablynx has forecast peak caplacizumab sales of 1.2bn. ... GSK's malarial vaccine, Mosquirix which also contains Agenus’QS-21 Stimulon, was

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  • Raising Awareness: Rare Disease Day

    Available at: . Last accessed: February 2017. 3.EMA. Orphan designation. Available at: Last accessed: February 2017.

  • Brexit and Pharma: A match made in hell.

    More than 600 full-time staff currently deliver this service in London, but many people are now asking whether the EMA has been made homeless. ... The EMA is just one example of the huge changes required in this whole adaptation process.

  • Wordbird tops the leader chart at the OTC awards

    Wordbird worked with HRA Pharma on the centralised EU switch of ellaOne from prescription to pharmacy, developing promotional materials for women and pharmacists as part of the EMA submission.

  • Life at the end of the Brexit tunnel

    We know that the EMA will be moving to mainland Europe, though we don't know the destination.

  • The Heart of the Matter 7: Reality Dawns

    Likewise, European pharmacovigilance legislation implemented in 2012 means the European Medicines Agency (EMA) is now requesting post-marketing observational studies as part of its approval processes.

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