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  • Article

    European Commission Publishes Updated Q&A On The Clinical Trials Regulation

    In December 2022, the European Commission published an updated version of the Q&A guidance on the Clinical Trials Regulation ("CTR"). This new version was issued shortly ahead of the 31 January 2023...
    European UnionCompliance
    Cooley LLP
    Cooley LLP
  • Article

    EMA Guideline On Sponsor Responsibility For Release And Shipping Of IMPs In Accordance With GCP And GMP In The EU Comes Into Effect

    The guideline on sponsor management of investigational medicinal products ("IMPs") for use in clinical trials that was published by the European Medicines Agency ("EMA") on 14 September 2022...
    European UnionCompliance
    Cooley LLP
    Cooley LLP

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