Morgane Lejeune

Morgane Lejeune is Senior Manager, Regulatory Affairs, CMC, PPD.

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    Article

    Considerations for sponsors when producing an EU IMPD: Impact of the EU-CTR

    2023-01-04T10:39:31.687

    European Union (EU) pharmaceutical legislation – known as the Clinical Trial Regulation (EU-CTR), came into effect on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a wider scale, with high standards of public transparency and safety for clinical trial participants.