Navigating the New EU Clinical Trial Regulation: 536/2014

The European Clinical Trial Regulation 536/2014 (CTR) will be coming into full effect in 2022, and will significantly change how companies conduct their trials. The CTR will replace the Clinical Trials Directive (2001/20/EC), which has been in effect since 2004.

In this whitepaper our panel discussed the changes, benefits and potential challenges that the new EU Clinical Trial Regulation No 536/2014 will bring when it is made effective. The team also reviewed how the CTR will different from the current EU Clinical Trials Directive 2001/20/EC which has been the principal legal directive in place since 2004, governing how clinical trials are conducted

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