Embracing the European Regulation in The Netherlands: VGO implementation status, its threats and opportunities

Background: In 2014, the European Clinical Trials Regulation was drawn up by the European Commission to replace the Clinical Trials Directive. The new Regulation aims to solve the shortcomings revealed by the Directive, such as extensive timelines and high bureaucratic costs, while increasing standards for safety and transparency of clinical trials. Importantly, the Regulation also points at harmonizing procedures among European Member States. From January 31st, 2022, it will be possible to submit clinical studies through a new portal, namely the Clinical Trials Information System. Since not c... Mehr ...