European Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 for Safety Assessment of Clinical Trials

On 10 January 2022 the EC released guidance on implementing the EU clinical trial regulation for Safety Assessment in Clinical Trials.

Regulation (EU) No 536/2014 lays down the legal framework for the conduct of clinical trials on medicinal products for human use in the Union to ensure that the rights of subjects (‘participants’), their safety and well-being are protected, and that the generated data are reliable and robust. In particular, while the overall responsibility for ensuring participants’ safety lies with the sponsor of the clinical trial, it is reinforced by additional oversight from the Member States including through their cooperation in the assessment of the safety of the investigational medicinal products.

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