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  1. proslijedio/la je Tweet
    4. velj

    To contribute to the global response to the outbreak of the novel infections, EMA is taking concrete actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus:

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  2. proslijedio/la je Tweet
    4. velj

    Recently, we outlined our approach to expediting development & availability of critical medical products to prevent, diagnose, & treat 2019-nCoV using all applicable regulatory authorities to respond to this outbreak.

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  3. prije 8 sati

    The European Medicines Agency has published the highlights for 2019 regarding medicinal products for human use. Find the list of highlights here:

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  4. proslijedio/la je Tweet
    30. sij

    European Commission Calls for Observers to Join Annex XVI Subgroup | Focus

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  5. proslijedio/la je Tweet
    31. sij

    EMA, MHRA Post Last-Minute Brexit Information | Focus

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  6. proslijedio/la je Tweet
    31. sij

    CHMP Recommends 15 Medicines, Extends Six Indications | Focus

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  7. 3. velj

    We are thrilled to announce that we will attend "Giornata di Studio AFI - Farmacovigilanza & Affari Regolatori" in Milan next week! Are you also joining this event?

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  8. proslijedio/la je Tweet
    30. sij

    A new challenge is now live! The purpose is to advance techniques for surveillance and detection of adverse events associated with FDA products. For more information and to get started, visit

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  9. proslijedio/la je Tweet
    31. sij
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  10. 3. velj

    Have you already read the key principles of a harmonised approach to develop and use electronic product information () in the European Union? Learn more about this document on 's website:

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  11. proslijedio/la je Tweet
    31. sij

    First oral GLP-1 treatment for type 2 recommended for approval. It provides patients with an option to treat the disease without injections

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  12. proslijedio/la je Tweet
    31. sij

    UK withdrawal from the EU on 31 January 2020: During the transition period, EU pharmaceutical law will continue to be applicable to the UK, meaning that pharmaceutical companies can continue to carry out activities in the UK until the end of the year. 👉

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  13. 1. velj

    The has released a statement, outlining the future for the UK’s industry in the transition period following and thereafter:

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  14. 31. sij

    The published a new guideline on Adaptive Design Clinical Trials for and . The guidance describes important principles for designing, conducting, and reporting the results from an adaptive CT:

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  15. proslijedio/la je Tweet
    31. sij

    First treatment for , a rare life-threatening genetic condition, recommended for approval

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  16. proslijedio/la je Tweet

    On April 1, 2020, the will hold a public meeting, Communications About the Safety of Medical Devices. During this meeting, we plan to discuss the development, content & format of the FDA’s safety communications for medical devices:

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  17. 30. sij

    Have you already seen the latest World Health Organization Pharmaceuticals Newsletter? Download it together with previous issues from the WHO website:

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  18. 30. sij

    PM Holding, a group of service providers in the Life Sciences industry that include Arithmos, CROS NT and seQure Life Sciences, announces the appointment of Jan Back as Marketing Director. Welcome, Jan!

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  19. proslijedio/la je Tweet
    27. sij

    What's on the agenda of the January meeting of EMA's human medicines committee

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  20. 29. sij

    Our pharmacovigilance team keeps growing! We are thrilled to announce that Michael Obispo Torres has just joined us as Safety Data Manager. Excited to have you with us, Michael!

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