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In brief

On 2 March 2021, the National Agency for Regional Healthcare Services (Agenas) published the Provider Verification Manual setting forth the national framework, established by the National Commission for Continuing Education, on the supervisory and verification activities performed by accreditation bodies on the compliance with Continuing Medical Education regulations by providers.


The manual is composed of two parts. The first one, dealing with the evaluation of the organizational structure of applicant providers and accredited providers, defines the rules for the verification of the minimum requirements and standards provided by the National Accreditation Manual for the provision of CME events, which represent an essential condition for achieving and maintaining provisional accreditation, standard accreditation and its renewal.

The second part, dedicated to the evaluation of CME training activities, regulates the way in which these evaluations are carried out and identifies the principles on which they must be based, including: independence of the training content from commercial interests; correct implementation of CME legislation on sponsorship, advertising and conflicts of interest; scientific and educational quality of the training content and consistency of the events with the planned training objectives.

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.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.