€5m Initiative To Help EU Member States Cooperate On Trial Safety Assessments
An EU funded project is to help national competent authorities cooperate on the safety assessment of clinical trials as required under the Clinical Trial Regulation.
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A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
The new workplan for the EU's initiative on accelerating clinical trials lays out the timelines for a set of “priority actions,” such as mapping the European clinical trial environment and establishing a consolidated process for more efficiently managing scientific advice on trials.
A new implementing regulation provides a legal basis for EU member states to cooperate on the assessment of trial-related safety reports linked to an active substance instead of the investigational medicinal product.