Whitepaper: EU Clinical Trial Regulation
The Regulation has been created to address the disharmonised interpretation of the Directive across EU countries, and the administrative and regulatory burden it imposes on the conduct of clinical trials.
The Regulation has been created to address the disharmonised interpretation of the Directive across EU countries, and the administrative and regulatory burden it imposes on the conduct of clinical trials.
Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products (IMPs). The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation (CTR) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS), formerly the EU clinical trial portal and database. The European Medicines Agency (EMA) will set up and maintain the new information system, in collaboration with the Member States and the European Commission (EC).
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