Background/Aim. Cardiovascular disease imposes a burden to society in terms of mortality, morbidity and economic losses. The aim of this study was to estimate the economic burden of cardiovascular disease in Serbia in 2009 from the perspective of the society. Methods. For the purpose of the study cardiovascular disease was defined by the International Classification of Diseases, 10th revision, as the following diagnosis: hypertension, coronary heart disease, cardiomyopathy, heart failure and cerebrovascular disease. The prevalence, top-down method was used to quantify the annual cardiovascular costs. Productivity losses were estimated using the human capital approach and the friction cost method. A discount rate of 5% was used to convert all future lifetime earnings into the present value. Results. The total direct costs of cardiovascular disease in 2009 were ? 400 million. The results showed that more than half a million working days were lost due to incapacity resulting from cardiovascular diseases, yielding the ? 113.9 million. The majority of total costs (? 514.3 million) were for: medication (29.94%), hospital days (28.97%) and hospital inpatient care - surgical and diagnostic interventions (17.84%). The results were robust to a change in 20% of volume or the unit price of all direct and indirect cost and to discount rate 2% and 10%. Conclusions. The total cardiovascular disease costs in 2009 represented approximately 1.8% of the Serbian gross domestic product. The results of the study would be valuable to health policy makers to bridge the gap between invested resources and needs, in order to improve cardiovascular disease outcomes.

Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to “medicinal products” and “marketing authorization(s),” the FDA documents discussed “drug(s)” or “biologic(s),” and the TGA documents referred to “biological(s).” Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis.

Vertebral fractures could lead to reduced physical, social and mental functioning, and loss of personal independence. Therefore, during the treatment of osteoporosis, it has become necessary to examine the changes in everyday functioning, well-being and health related quality of life (HRQOL). To that effect, this study aims to translate, culturally adapt, and validate the Serbian version of Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41) for patients with vertebral fractures.

A wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were “biological,” “product,” and “medicinal,” respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified “quality” and “appropriate” as main concepts, whereas in Good Clinical Practice (GCP) documents it was “clinical,” followed by “trial,” “subjects,” “sponsor,” and “data.” GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level.