Search for:

In brief

On 30 January 2023, the European Commission published a document on the application of Regulation UE 536/2014 on clinical trials to provide sponsors and investigators with a quick guide on the rules and procedures established in the same Regulation with a view to facilitating its implementation (“Guide“).

Key takeaways

The Guide concisely covers the different phases of clinical trials, focusing on the obligations of investigators and sponsors, including those concerning the reporting and notification of adverse events.

In addition, the Guide describes the various steps to be followed when submitting a clinical trial application through the CTIS (“Clinical trial information system”) which, as of 30 January 2023, has become the single point of access for submission, authorization, and supervision of clinical trial applications in the EU.


Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Write A Comment