European Regulatory Affairs Process with EMA and other Regulatory Authorities

Course "European Regulatory Affairs Process with EMA and other Regulatory Authorities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

    EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines.
    In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
    EMA's success is based on cooperation within the European medicines regulatory network - a unique partnership between the European Commission, the medicines regulatory authorities in the European Economic Area countries, and EMA. Working together has encouraged the exchange of knowledge, ideas and best practices, to ensure the highest standards in medicines regulation.
    Today, seven EMA scientific committees and more than 30 working parties provide scientific expertise for the regulation of medicines by drawing on a pool of several thousand European scientific experts from the network.
    And Much More...