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By promoting the principles of sustainable development, educating the population and employees in all sectors about the opportunities for practical implementation, it encourages people to gather and work together to design and implement sustainable development in their communities. Great importance should be given to, and as such, commented on, new orientations at the level of public policies at the global, European and national levels. Also, great attention should be paid to changes in society.Global Sustainable Development Goals should be universal and, as such, applicable in all countries and communities, across the population. Their implementation should take into account specific opportunities, conditions and opportunities in different parts of the planet. Priority areas of action need to be identified and opportunities for contributing to sustainable development considered. In this way, we become part of a global partnership that is key to achieving the goals.In order for planning and implementation to be successful, significant mobilization of resources from different sources must be ensured. It is also possible to create clear public policies at national, regional and international levels through increased development cooperation, which is mainly based on development strategies that promote the fight against poverty and gender inequality. In this way, the promotion of gender equality creates the basis for prosperous and sustainable development.Another possible policy is to raise the level of economic productivity while pursuing diversification; technological development and innovation, all through the focus of work intensity. The condition for the development of these policies or strategies is achievable with the economic, social and environmental links with urban and rural areas.

The goal of my research is a sustainable development that is perfectly designed and defined as an idea, but in its implementation we encounter difficulties, depending on the demographic picture of the country, political organization, cultural differences, etc. However, in order for sustainable development to take place on the "right path" in all segments of our society, we need a strategy, but even if it were, the question arises: "In a world that relies on money as the main indicator of everything, Sustainable development or the natural resources that we need to leave to future generations have any chance of existence ? " In this sense, sustainable development is a harmonious relationship of environmental protection, economics and social development in order to preserve the resources of our planets for future growth. This is the general direction to create a better world for future generations by trying to balance the social, economic and environmental factors of the environment. The application of this concept varies depending on the branch in which the company is located, from the characteristics of the complete national environment in which the company operates. Because the economies of each country have emerged as a result of different historical and socio-economic factors, the institutional framework is different from country to country in the European Union.

Life under conditions of dynamic change imposes a need for creating the future, managing ideas and talents, and this can only be achieved by capable leaders. Recognizing their need, both for organizations and society as a whole, interest in leadership is growing more and more. Leaders have always been in a prominent position in the organization, have always aroused the greatest attention, as they have the most impact on the performance of each organization. This also shows the importance of leadership that emanates from the capabilities of leaders to create a vision and to direct their energy towards achieving that vision. The focus of our research effort is to find out the ways in which leaders will involve and motivate their employees, bearing in mind the specific and important role of each individual within the organization. Nowadays, they can use numerous motivation strategies for employees, which are used extensively in modern organizations, such as: material stimulation, work enrichment, employee participation, MBO management, recognition and praise, advancement, career development, etc.

The attitude of society towards education change due to changes in the needs for education, shifts of young people's attitudes and preferences, the dynamism of life, the demand for “ad hoc” learning that saves time and practical applicability of the acquired knowledge, and the pursuit of quick professional realization. This means that the conventional training methods should either be modified or replaced with new methods that would meet these requirements. Such a new method is the gamification – an educational approach to learning by using video game design and game elements. Its goal is to maximize enjoyment and engagement through capturing the interest of learners and inspiring them to continue learning. This paper investigates some of the most popular types of computer games whose logical structures can be used to develop training games. Gamification is compared with the case-study approach in terms of automated computing, student feedback throughout the training process, changes that may be made in the course of the game to create new situations to which trainees are required to respond, achievement rate feedback, gradual increase of the game difficulty level by setting increasingly difficult tasks. The comparison clearly outlines the advantages of the new approach, viz. greater learners’ enjoyment of the learning content, improved engagement and more active participation in the learning process. The paper presents six models of computer games that can be used for training in the field of business planning in both secondary and higher schools (forecasting a company's market share, organizing production at minimal cost, profit maximization, risk mitigation, sales and output planning, and optimization of return on equity.) Each game is described in terms of the input data that should be provided to the participants at the beginning of the game, parameters that will be changed in the course of the game, restrictive conditions, and the role of the player/trainee.

The aim of this study is to trace and analyze the public reporting of medicinal products’ expenditure paid by the National Health Insurance Fund (NHIF) for outpatient care since its establishment (June 2000) in Bulgaria. The analysis of financing from the NHIF for the period 2000-2016 shows an increasing expenditure of medicinal products for outpatient care. There is a big increase of the medicinal products’ spending paid by the NHIF budget for 2012 - 495.5 million BGN (which means 104.5 (21%) million BGN more than the previous 2011. As a result of this analysis it was found out that there is scarce fragmentary chronological public reporting traceable by indicators for outpatient care expenditure since the National Health Insurance Fund establishment. The reports published on the NHIF’s website provide partial information only about total expenditure for health insurance payments for medicinal products for outpatient care.

Purpose: Gene therapy brings opportunities to discover cures for diseases for which there are no adequate treatments. As most gene therapies target rare diseases, several challenges are associated with their clinical development, such as limited population size, lack of established clinical pathways for development, and sometimes the absence of validated endpoints. The objective of this study was to systematically review and evaluate the methodology and design of European clinical trials (CTs) utilising gene therapy medicinal products (GTMPs). Methods: A systematic search of online CT databases was performed using keywords to identify CTs conducted with GTMPs in Europe, published from 1 January 1995 to 31 July 2019. Results: The search identified 1571 CTs, of which 199 were identified as published articles. A total of 159 CTs remained following the elimination of duplicated CTs, non-gene therapy trials, and those conducted outside Europe. Of these, only nine CTs were randomised, double-blind, with or without parallel groups, and placebo-controlled. Conclusions: The analysed randomised CTs were conducted in accordance with Good clinical practice with low risk of bias across domains. Only one CT was identified with some concerns of bias due to lack of information regarding the randomisation process and changes in protocol.

International audience; Background: Claims included in package inserts (PIs) for medicinal products approved by the US Food and Drug Administration (FDA) constitute the regulatory definition of drugs' benefits and risks. Objective: We sought to assess the usage of patient-reported outcome (PRO) claims in a comprehensive set of US FDA orphan drug approvals dated between 1/1/2012 and 31/12/2016, and characterize them. Study design: Orphan drug approval documentation was obtained from the US FDA website. Drug Package Inserts (PI) were analyzed to extract information on PRO-related language. Results: Among 178 drugs that met inclusion criteria, 16 (9%) products approved for 16 orphan indications contained PRO language in the Clinical Studies section of the PI. All PRO instruments concerned disease symptoms, and two also referred to patient functioning. The most common PRO instrument was a bleed-specific rating scale for four products approved for the treatment or prevention of bleeding episodes in patients with genetic bleeding disorders. Conclusions: There is a need to implement public incentives for academic development of PRO instruments for rare conditions and for regulatory policies that mandate the collection of PRO endpoints in pivotal trials of orphan drugs.

Background: An elevated level of low-density lipoprotein cholesterol (LDL-C) constitutes one of the most important modifiable risk factors for cardiovascular disease (CVD). Individuals with heterozygous familial hypercholesterolaemia (HeFH) are particularly vulnerable to CVD events. The addition of evolocumab to statins has shown marked reductions in LDL-C levels. The objective of this analysis is to demonstrate the clinical and economic value of LDL-C lowering with evolocumab from the Bulgarian public health care perspective. Methods: A disease-specific measure of health benefit was devised: Effectively treated patient-years (ETPYs) combine length of life with the likelihood of attaining best-practice recommendations on LDL-C lowering. “Effective treatment” was defined as a reduction in LDL-C levels of ≥50%. A Markov cohort state-transition model was adapted, considering a life-long treatment duration. Demographics, baseline characteristics and efficacy data were taken from the RUTHERFORD-2 trial. The model uses the relationship between LDL-C lowering and reduced CVD event rates observed in the meta-analyses conducted by the Cholesterol Treatment Trialists’ Collaboration. Outcomes and costs (from year 2015) were discounted at an annual rate of 5%. Sensitivity analyses were conducted to assess uncertainty surrounding the results. Results: The total incremental costs of evolocumab added to statins versus statins alone are BGN 120,329 while adding 9.30 ETPYs over lifetime. These results imply an incremental cost per ETPY of BGN 12,937 (US$ 7,215; € 6,604). The use of evolocumab is associated with a relative reduction in the CVD event rate by 38% (18% per 1 mmol/L). Conclusions: Adding evolocumab to statins may be considered cost-effective in light of an additional expense per patient-year gained in which individuals with HeFH receive effective treatment under the terms of international prevention guidelines. ETPYs are an intuitive and clinically meaningful measure of patient benefit that, in relation to costs, can support health care decision-making that considers quality of care.

Background: The Trump administration's 'American Patients First' blueprint proposes to reduce drug prices in the USA by increasing drug prices abroad, ex USA. The possibility of the Trump administration to raise drug prices ex USA through legal action via the WTO and bilateral negotiations with foreign trade partners was reviewed. Methods: A literature review was conducted through PUBMED, EMBASE, Media and grey literature to consolidate publications of the Trump administrations' policies and strategies towards foreign countries and drug prices. Results: The Trump administration has withdrawn from and halted major multilateral agreements including the TPP, Paris Agreement, TTIP, UNESCO, NAFTA (now USMCA), and NATO. The Trump administration has been successful in bilateral negotiations for pharmaceuticals' pricing, as seen with Japan, South Korea, Germany, and Mexico and Canada. Conclusion: The objective of raising prices abroad is attainable. Action through the WTO is unlikely, due to its nondiscriminatory principle. Bilateral trade negotiation have proven more promising. In this bilateral framework, financial security and military protection are strong assets for the USA to levy higher drug prices abroad. Although raising drug prices ex USA is possible, further questions as to whether this will directly translate into lower drug prices for American patients are raised. ispartof: J Mark Access Health Policy vol:7 issue:1 pages:1650596- ispartof: location:United States status: Published online

Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan drug approval documentation was obtained from the EMA website. PRO-related language was extracted from the Summaries of Product Characteristics (SmPCs). Data were compared to a previously published analysis of the FDA approvals from the same time period. Results: Out of 60 approvals that met the inclusion criteria, 12 products approved by the EMA for 13 (21.7%) orphan indications contained PRO language in the Clinical Studies section of the SmPC. Twelve SmPCs contained PRO instruments based on symptoms, five of which also concerned patient functioning. Eight approvals included PRO claims related to quality of life (QoL) most commonly in cancer treatment. Conclusion: The rate of PRO claims was lower for orphan drugs specifically than for all drug approvals by the EMA. However, in accordance with previous findings, the EMA appeared more inclined to grant PRO claims including health-related QoL than the FDA.