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Roberto Cursano

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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.

On 16 February 2022, the Medical Device Coordination Group approved a new document to provide guidance to Notified Bodies on the appropriate way to carry out surveillance activities on CE-marked devices in accordance with the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC, which, by virtue of the provisions of Article 120(3) of Regulation EU 745/2014, can be marketed until 26 May 2024.

On 23 March 2022, the “National Ethics Committee for trials conducted by public research organizations and other public organizations of a national nature” (“National Ethics Committee”) was established within the National Institute of Health (NIH) in accordance with the provisions of the decree of the Ministry of Health dated 1 February 2022. The National Ethics Committee was settled on 23 March at the Italian NIH to replace the Ethics Committee of the NIH, which has been in office until now.