Kurzfassung: A methodology has been developed for assessing the region’s human capital based on the calculation of an integral indicator. The modern economic development trends, expressed in the activation of digitalization processes, are considered. The place of the Voronezh region in terms of digitalization among other regions is determined. The region occupies a leading position among the studied areas, but at the same time, further development in the direction of digitalization is necessary, since the region has the resources for higher rates of digitalization in the long term. Under the assumption that human capital plays a key role in the process of transformation of the modern economic system of the region, the authors propose a system of indicators for an integrated assessment of the human capital of the region. Indicators are united in enlarged groups (demographic, labor and educational, research, sociocultural). To calculate the integral indicator of the state of human capital in the region, the coefficients of significance of each of its components are determined. Significance factors were established using an expert method. Next, we calculated the weighted indicators for assessing the components of the region's human capital and the integral indicator. The calculations made it possible to determine the key components in the structure of indicators of human capital: labor and educational, which made it possible to orient the directions of development of human capital in the regions. Particular attention is paid to the development of the innovation sphere, which cannot be realized without the development of human capital. The results of empirical studies have confirmed the possibility of practical use of the developed methodology for assessing the human capital of the region, allowing to assess its condition and identify key areas of development.

Kurzfassung: The article is devoted to the study of modern approaches to assessing the effectiveness of the risk management system (RMS) of an organization, presented in current risk management standards, regulator recommendations and in the scientific literature on this issue. Based on the assumption that the effectiveness of the risk management system can be assessed by comparing the achieved result with the RMS efficiency criterion, the authors studied the methodological approaches and evaluation criteria proposed in the documents regulating risk management, as well as by specialists. As a result of the analysis, it was found that in the specialized literature on the problem of risk management, there is no generally accepted definition of the effectiveness of RMS, as well as clear criteria for its evaluation. An analysis of approaches to assessing the effectiveness of the RMS made it possible to identify the key elements and processes of risk management. Criteria and methodology for evaluating the effectiveness of the organization's risk management system are proposed, taking into account the degree of implementation and the effectiveness of the functioning of the RMS elements. Evaluation of the effectiveness of the risk management system will become increasingly relevant. This is facilitated by the changing working conditions of organizations and the objective needs of risk management entities and stakeholders. According to the authors, assessing the effectiveness of risk management systems allows you to obtain reliable information about the flow of business processes and identify problem blocks that impede the achievement of the organization's goals. Such information should be taken into account in the process of making managerial decisions at all levels of management.

Kurzfassung: The article is devoted to the study of the influence of the development of innovations on the economic security of the regions. Based on the assumption that innovative development plays a key role in the process of ensuring the economic security of the region, the authors proposed a system of indicators for assessing the innovative component of the economic security of the region, including the indicators of economic security reflected in the Decree «On the Strategy of Economic Security of the Russian Federation for the Period up to 2030». The impact of innovations is realized through the achievement of the goals of ensuring the country's security, among which is the dynamic and progressive development of the economy. The authors proposed a methodology for assessing the innovative component of economic security based on the scoring method, developed an assessment scale for interpreting the results of calculations, assessed the innovative security of regional economic systems of the Federal Districts of Russia for the period 2015–2019. As a result of the analysis, factors were identified that hinder innovative development and negatively affect the provision of economic security at the regional level: underdevelopment, low efficiency of the innovation infrastructure, reduction of internal costs for research and development, a decrease in the number of developed advanced production technologies, and others. It has been established that the economic security of a region depends on its ability to perceive innovations, while institutional factors have a significant impact on the pace of development. The work has improved the methodological tools for diagnosing the innovative security of the regions of the Russian Federation by optimizing the system of criteria for its assessment. The results of the empirical studies carried out confirmed the possibility of practical use of the developed methodology for diagnosing the innovative security of the regions of the Russian Federation and identifying priority areas for its improvement.

Kurzfassung: Relevance . In accordance with the guidelines on the clinical investigation of clotting factor VIII products of the European Medicines Agency and guidelines on pharmacovigilance of the Eurasian Economic Union, after registration of a new drug, it is recommended to study its efficacy and safety on a large population of patients in a standard medical practice to clarify and identify new data. Materials and methods . In a prospective, multicenter, open-label, uncontrolled observational study, the efficacy and safety of the domestic recombinant B-domain deleted blood clotting factor FVIII (FVIII) (moroctocog alfa, Octofactor®, JSC “GENERIUM”) in patients with moderate and severe hemophilia A in the context of standard medical practice (study protocol number CI-51/15). Patients received the drug in terms of standard medical practice for the purpose of prophylactic treatment or on demand treatment. For prophylactic treatment Octofactor was administered to patients according to the instructions for medical use in a single dose of 20–40 IU/kg every 2–3 days. In the case of bleeding a single dose of Octofactor was calculated taking into account the severity and localization of bleeding in accordance with the instructions for medical use. The results of the treatment were analyzed for a period of 52 ± 2 weeks. The main parameter for evaluating the efficacy was the frequency of spontaneous bleeding that occurred within 48–72 hours after the administration of the Octofactor. Additional parameters for evaluating the efficacy included: the severity of spontaneous bleeding arising during the prophylactic treatment; the number of injections and the total dose of the Octofactor to stop 1 episode of bleeding; the amount of Octofactor used during the entire observation period (52 ± 2 weeks) and for 1 month both for prophylaxis and for stopping the bleeding that occurred; an indicator of the efficacy of therapy on the scale for determining the response to treatment of acute hemarthrosis (World Federation of Hemophilia, WFH). Results. According to the results of the screening survey 237 male patients aged from 19 to 78 years old (mean age 35.2 ± 11.1 years) with moderate and severe hemophilia A (FAS-population) were included in the study. The efficacy of therapy was evaluated in 202 patients who underwent all the planned procedures during the observation period (PP-population). 193 (95.5 %) patients received prophylactic treatment, 9 (4.5 %) patients received on-demand treatment. Evaluation of the efficacy of treatment was carried out on the basis of basic and additional parameters. The main parameter for evaluating the efficacy – the frequency of spontaneous bleeding that occurred within 48–72 hours after the administration of the Octofactor – was 52 ± 2 weeks within 1.4 ± 2.9 cases. At the same time, the proportion of spontaneous bleeding that occurred within 48–72 hours after administration of the Octofactor preparation was 45.2 % of the total number of spontaneous bleeding and 15.6 % of the total number of all bleeding in patients who received prophylactic treatment. Among 608 spontaneous bleeding that occurred in patients receiving prophylactic treatment, 287 (47.2 %) of the bleeding were mild, 289 (47.5 %) were moderate and 32 (5.3 %) were heavy. Of the 275 spontaneous bleeding that occurred within 48–72 hours after administration of the study drug for prophylactic purposes, 117 (42.5 %) episodes were mild, 146 (53.1 %) were moderate, and 12 (4.4 %) were severe. With prophylactic administration the average single dose of the Octofactor was 2036.3 ± 884.7 IU, or 27.3 ± 11.2 IU/kg, in the treatment of bleeding occured during prophylactic treatment – 2227.7 ± 1087 IU, in the treatment of bleeding in patients receiving the drug only on demand – 2280.7 ± 1037.2 IU. The average monthly intake of the drug by one patient in prophylactic treatment was 19.75 ± 9.75 thousand IU, while the average monthly consumption of the drug for preventing bleeding from one patient was 17.16 ± 9.13 thousand IU for stopping bleeding against the background prevention – 3.87 ± 3.97 thousand IU. One patient who received on-demand treatment had an average monthly average of 13.47 ± 13.46 thousand IU of the Octofactor preparation. For stopping 1 bleeding, on average, 1.7 ± 1.7 injections of the Octofactor preparation were required, in the prophylactic treatment group – 1.8 ± 1.8, and in the on-demand treatment group – 1.5 ± 1.1. In the overwhelming majority of cases, patients of both groups showed excellent and good response to all treatment of acute hemarthrosis on the scale of the WFH on all visits, the reaction was moderate in a few episodes, and only in 1 case of acute hemarthrosis there was no response to the drug administration. The safety of therapy was evaluated in 228 patients who received at least 1 Octofactor administration during the study (mITT-population). There were 66 adverse events in 40 patients, 10 of them were associated with the use of the drug, the most significant of which were the formation of inhibiting antibodies to FVIII in low titer (1.5 U) in 1 patient and the development of allergic reactions in 2 patients. Conclusions. Under the conditions of standard medical practice the efficacy and safety of Octofactor was confirmed for both prophylactic treatment and on-demand bleeding treatment in adult patients with severe and moderate hemophilia A.