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Clinical trial regulation
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  • Clinical Trial Regulation - Key considerations to be aware of with CTR

    Key considerations to be aware of with Clinical Trial Regulation (CTR) EU No 536/2014

    The Clinical Trial Regulation (Regulation (EU) No 536/2014) will replace the Clinical Trials Directive 2001/20/EC and aims to ensure a higher level of harmonization of the rules for authorizing and conducting clinical trials throughout the EU thus making it more attractive to conduct clinical trials in the EU. The new regulation goes into effect on the 31st of January 2022.

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