Under the provisions of the Ordinance on Clinical trials and Good Clinical Practice (Official Gazette No. 121/07) and Ordinance on Clinical Trials of Medicinal Products and Good Clinical Practice (Official Gazette No. 25/15) the scope of work of Central Ethics Committee (CEC) is:
- to issue opinions in the procedure of granting approvals for clinical trials of medicinal products and/or medical devices, including academic clinical trials;
- to issue opinions in the procedure of granting approvals for non-interventional trials;
- to accept non-substantial amendments to previously approved clinical trial protocols;
- to issue opinions in the procedure of granting approvals for substantial amendments to the approved clinical trial protocols; and
- to accept final clinical trial reports.
The Central Ethics Committee is an independent committee of 19 members, healthcare professionals and members of non-medical professions.
The president of Central Ethics Committee, his deputy and members of the Committee are appointed by the minister responsible for health.
Administrative support for the activities of the Central Ethics Committee is provided by the Agency for Medicinal Products and Medical Devices.
- Assist. Prof. Suzana Mimica Matanović, M.D., Ph.D.
- Assist. Prof. Iveta Šimić, M.D., Ph.D.
- Ivica Belina, M.A. (Education and Rehabilitation Sciences)
- Prof. Vlasta Bradamante, M.D., Ph.D.
- Assist. Prof. Natalija Dedić Plavetić, M.D., Ph.D.
- Viktorija Erdeljić Turk, M.D., Ph.D.
- Davorka Herman Mahečić, M.D.
- Prof. Marija Jelušić, M.D., Ph.D.
- Assist. Prof. Katica Knezović, Ph.D.
- Prof. Arijana Lovrenčić Huzjan, M.D., Ph.D.
- Assist. Prof. Eduard Margetić, M.D., Ph.D.
- Prof. Jasminka Milas-Ahić, M.D., Ph.D.
- Prof. Dinka Pavičić Baldani, M.D., Ph.D.
- Marija Pećanac, L.L.B.
- Delfa Radić-Krišto, M.D., Ph.D.
- Prof. Nadan Rustemović, M.D., Ph.D.
- Academician Miroslav Samaržija, M.D.
- Prof. Melita Šalković Petrišić, M.D., Ph.D.
- Prof. Dinko Vitezić, M.D., Ph.D.
The President, President's Deputy and members of the Central Ethics Committee were appointed by the Decrees of the Minister of Health from June 24, 2016 and October 4, 2016 (Class: 080-01/16-01/29, Not. Nr.: 534-10-1/1-16-2 and Class: 080-01/16-01/29, Not. Nr.: 534-10-1/1-16-4, respectively).
CEC rules of procedure governing its work may be seen at the links below: