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Product Regulation & Liability

Italy: AIFA – Updated list of self-certified phase I clinical trial facilities

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In brief

On 6 February 2024, the AIFA published the updated list of self-certified healthcare facilities allowed to perform phase I clinical trials pursuant to Determination No. 809/2015, which defines the minimum requirements for such centers.

The list is divided by region and acknowledges the operational status of the various facilities.

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Author

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.

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Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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