The two Italian National Ethics Committees for clinical trials will evaluate the study protocols of their respective competencies on a monthly basis.
On 1 February 2022, the Minister of Health established the National Ethics Committee for clinical trials relating to advanced therapies and the National Ethics Committee for clinical trials in the pediatric field.
The two CENs established at AIFA, the Italian competent authority, became fully operational with the registration in the Clinical Trial Information System (CTIS).
The task of the two Committees is to evaluate the study protocols falling within their respective competences. To this end, ordinary sessions are scheduled on a monthly basis.
They will be chaired by Prof. Andrea Biondi and Dr. Alessandro Nanni Costa respectively. The presidents are assisted in their activities by the members appointed with the ministerial decrees of 2 March 2022.
Two specific technical-scientific Secretariats and a Coordination Group have also been set up to support the CENs.