Contact Person
    Nicole Mastrell

    Event Manager & PA to CEO
    Email: nm@mva.org
    Phone: (M) +45 6141 8634
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    Nitrosamines – New requirements to evaluate contamination risks

    Nitrosamines – New requirements to evaluate contamination risks 

    Between 2018 and 2019, authorities in Europe became aware of the presence of Nitrosamine molecules in several commercialized human drugs. Nitrosamines were brought in such formulations as contaminants of APIs such as Valsartan and other Sartans, Pioglitazone and Ranitidine. Several Nitrosamines are classified as probable human carcinogens. As a precaution, in September 2019 the European Medicines Agency (EMA) requested to all Marketing Authorization Holders (MAHs) to evaluate the risk of Nitrosamines presence in their commercialized formulations by October 1st, 2020.

    As a trusted API and excipient supplier, Merck initiated a risk evaluation campaign aimed to provide MAHs with an assessment on the presence of Nitrosamines on each of their Emprove® raw materials.

    If you are interested to learn Merck approach to this risk evaluation and understand how Merck can support you in your risk assessment for Nitrosamines, we invite you to join the conference call on Thursday, June 4th, at 10:00 (CET).

    Date: June 4th, 2020
    Time: 10:00 – 11:00
    Venue: Microsoft Teams (conference call)

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     About

    The conference call outlines the following:

    • European Medicines Agency (EMA) Information on Nitrosamines for Marketing Authorization Holders.
    • Principles of Risk Assessment for Nitrosamines content in human medical drugs.
    • Merck approach on APIs and excipients.