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Publication
The EU Clinical Trials Regulation Experiences from the first 18 months
Feb 12, 2024
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  • The EU Clinical Trials Regulation Experiences from the first 18 months

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The new EU Clinical Trials Regulation represents the most significant overhaul of clinical trial requirements in Europe for a generation, and this article describes the insight gained during the months following the implementation of this new regulation. The article reviews the implications for sponsors, describes the experiences and lessons learned of an organization submitting many clinical trial applications during this time, and looks to the near future as the regulation becomes fully established.

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