EU Clinical Trials Regulation (CTR) No 536/2014 – Are You Prepared?

Further to PCI’s previous Water Cooler Chat around the Impact of the EU Clinical Trials Regulation No 536/2014, we dive into our second session on the topic and answer any additional questions.

As the CTR go-live date approaches, this chat looks in more detail at some of the pros and cons of the Regulation. Furthermore, we discussed how sponsors can best prepare for applications via the Clinical Trial Information System and the challenges and changes that will come as a result of the requirements of Annex 6 labelling.

Our dedicated team of specialists will be happy to discuss any of your Clinical Trials Regulation questions or concerns. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email

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