By Dragana Maca Kastratovic, M.D.
In May, the celebration of the “International Day of Clinical Trials” was organized by the Center for Clinical Pharmacology, Clinical Center of Serbia, in the Polyclinic of the CCS. The International Day of Clinical Trials is May 20, which commemorates the first comparative trial conducted in 1747 on 12 sailors afflicted by scurvy.
On behalf of the Clinical Center of Serbia, the meeting was opened by Professor Dr. Svetozar Damjanovic, a Scientific Research Manager. His introductory lecture was called “The significance of clinical trials for the development of the Clinical Center of Serbia.”
Professor Damjanovic reported on past activities and results in respective fields, as well as the huge potential for the future. He emphasized that, by implementing the EU Directive for Clinical Trials, Serbia would have a chance to work in the same way as the best research settings in Europe and worldwide.
The European Union Clinical Trial Directive was passed by the Ministry of Public Health of the Republic of Serbia and incorporated in the Serbian Act, which encompasses the regulations governing clinical trials of drugs, procedures and contains the documents for approval of clinical trial, Official Gazette No 19/2007.
Thus, clinical trials in Serbia will be performed officially in the same way as in other EU countries. Dr. Vasilije Antic, senior consultant gave a presentation on this Act with a special focus on the part referring to inclusion of vulnerable populations into clinical trials of drugs.
The celebration was also enhanced by internationally distinguished lecturers who had participated in the preparation and passing of the Serbian Act and the implementation of the EU Directive in both The Netherlands and France.
Professor Herman Pieterse, Ph.D., delivered a very interesting and beneficial lecture called “Clinical research with medicinal products in compliance with regulations and a no-nonsense approach.” Then, he answered all questions posed by physicians and highlighted the significance of education in clinical research as a prerequisite to working in that field.
On the same day, we celebrated the incorporation of the Clinical Center of Serbia into the European Clinical Research Infrastructure Network and Biotherapy Facilities (ECRIN) project. Assistant Professor Christian Kubiak gave a presentation about ECRIN. The ECRIN project originated in France, and is the brainchild of Jacques Demotes-Mainard, M.D., Ph.D.
I also gave a lecture on the following topic: “Clinical Centre of Serbia – What is our role in global drug clinical trials?”
I spoke about the features of the Clinical Centre of Serbia, the largest research institution in our country, which has standards that would meet any criterion to attract studies from the EU, U.S. and Japan. I stressed also the advantages of successful implementation of the EU CT Directive in Serbia. I had no reason to hide my joy about the forthcoming collaboration within the ECRIN Project and the deserved position of the Clinical Centre of Serbia in the plan.
CCS General Director - Prof. Dr. Vojko Djukic, Director of Personnel Department - Zoran Petkovic, to Ministry of Public Health of Serbia, Drug Agency and Section for Clinical Pharmacology of Serbia collaborated to produce this excellent outcome.
The celebration concluded with a fashion show, presenting professional healthcare attire tailored by Konstancia, which embodied the attitude toward conducting business in the public health service sector and in applied science in medicine.
The celebration overall made clear Serbia’s intention to achieve world standards and results.
Dragana Maca Kastratovic, M.D., Specialist Clinical Pharmacology Chief at the Clinical Centre of Serbia.