scholarly journals Current Approaches to Demonstration of Therapeutic Equivalence of Locally-Acting Gastrointestinal Drugs

2021 ◽  
Vol 11 (4) ◽  
pp. 228-238
Author(s):  
E. V. Gorbunova ◽  
D. V. Goryachev ◽  
T. E. Gorskaya ◽  
A. N. Bogdanov
Keyword(s):  
Russian Federation ◽  
Methodological Approach ◽  
Test Methods ◽  
Careful Consideration ◽  
European Medicines Agency ◽  
Special Focus ◽  
Therapeutic Equivalence ◽  
Medicinal Products ◽  
The Russian Federation

Evolution of knowledge about pharmacokinetics and pharmacodynamics of locally acting products, and an increase in the number of generics and medicines under development have laid the ground for the development of new scientific approaches to planning and conducting of therapeutic equivalence studies of medicinal products acting locally in the gastrointestinal (GI) tract. To date, many international guidelines on planning and conducting of bioequivalence (BE) studies of locally acting GI products have been updated, however, there are still no such guidelines in the Russian Federation and the Eurasian Economic Union (EAEU). Therefore, elaboration of common methodological approaches to the planning of clinical studies of these products is of particular relevance for the EAEU. The aim of the study was to analyse foreign approaches to planning, conducting, and evaluation of therapeutic equivalence studies of locally acting GI products. The paper analyses the guidelines of the European Medicines Agency and the US Food and Drug Administration on the planning, conduct, and evaluation of BE studies of locally acting GI products. The analysis demonstrated that BE clinical trials are giving way to in vitro studies providing a sensitive and accurate assessment of the differences between a locally acting GI product and the reference product, based on careful consideration of the medicine’s mechanism of action, dosage form, and site of action. The paper gives examples of test methods applied to medicinal products with a complex biopharmaceutical profile whose bioequivalence assessment is challenging, with a special focus on mesalazine products. The results of the analysis may be used for elaboration of a harmonised methodological approach to planning and conducting therapeutic equivalence studies of locally acting GI products in the Russian Federation and EAEU.

Updating the methodology for providing incentive subsidies to depressed agricultural regions

2020 ◽  
Vol 19 (12) ◽  
pp. 2210-2224
Author(s):  
V.M. Sharapova ◽  
T.N. Medvedeva ◽  
E.A. Farvazova
Keyword(s):  
Russian Federation ◽  
Agricultural Sector ◽  
Methodological Approach ◽  
State Regulation ◽  
The State ◽  
State Support ◽  
Agricultural Producers ◽  
The Russian Federation ◽  
Depressed Regions ◽  
Agricultural Regions

Subject. The article considers a procedure for calculating and distributing State support to depressed agricultural regions in the framework of a new type of budget financing, i.e. compensating and stimulating subsidies. Objectives. The purpose is to evaluate the efficiency of the system of State regulation of agribusiness in a depressed region, determine the priority of modern methods of budgetary support from the State, improve the methodological approach to the distribution of State aid among subjects of the Russian Federation with low level of socio-economic development. Methods. The study draws on the abstract and logical method, methods of statistical analysis, grouping, comparison, and generalization. Results. We realized the objectives of the study, using the agricultural producers of the Kurgan Oblast case. The paper analyzes the condition of agricultural sector in the depressed region, assesses the State support system efficiency for the agricultural sector of the Trans-Ural region, considers government measures related to the regulation of the economy of backward regions. It presents an updated method of budget financing within an incentive subsidy by clarifying the calculations and introducing an additional indicator that reflects the level of remuneration of regional agricultural producers. Conclusions. The updated calculation methodology for incentive subsidies to depressed regions enables to build a certain economic rating of ten depressed regions of the Russian Federation, taking into account not only the volume of production and employment, but also the level of wages of agricultural workers.

scholarly journals Analysis of the economic security of regions taking into account the indicators of innovative development

2020 ◽  
Vol 18 (4) ◽  
pp. 104-121
Author(s):  
Vladimir I. Byvshev ◽  
Irina A. Panteleeva ◽  
Anastasia E. Kashirina ◽  
Kristina V. Parfentieva ◽  
Danil I. Uskov
Keyword(s):  
Russian Federation ◽  
Methodological Approach ◽  
Threshold Value ◽  
Economic Security ◽  
Task Orientation ◽  
Innovative Development ◽  
Regional Innovation ◽  
Regional Economic ◽  
The Russian Federation ◽  
The Stability

The article considers some current scientific approaches to assessing regional economic security and notes the lack of an innovative component in them. However, innovative factors are necessary, since one of the main directions in the field of economic security is innovative development. The purpose of the research is to develop and test a modified methodological approach to the formation of indicators for assessing regional economic security, taking into account innovative factors. The authors generated extremely modified approach to assessing the economic security of the region, taking into account such principles as: task orientation, comprehensiveness, comparability, sufficiency, information security, applicability in practice. The authors developed an algorithm for studying the economic security of the region, formed a system for assessing the economic security of the region taking into account innovative factors, and calculated threshold values and evaluated a sample of regions according to the described methodology. As a result, it is concluded that the regions are diverse in terms of economic security and actually correspond to the conditional division in terms of socio-economic and innovative development. The most vulnerable for the majority of the subjects of the Russian Federation considered was the innovation component, the threshold value of which should have been determined in the stability zone, but most of the regions did not pass. Thus, it is necessary to study this topic in detail, namely, to assess the functioning of the regional innovation infrastructure and its impact on the economic security of the region due to the fact that the creation of conditions provided by its activities is one of the main strategic directions for strengthening the economic security not only of the region, but also of the Russian Federation as a whole.

scholarly journals Evaluation of the Governmental Agency Effectiveness in the Russian Federation

Lex Russica ◽  
2020 ◽  
Vol 73 (6) ◽  
pp. 68-76
Author(s):  
S. A. Lubennikova
Keyword(s):  
Russian Federation ◽  
Subject Matter ◽  
Methodological Approach ◽  
Social Indicators ◽  
National Level ◽  
Evaluation Criteria ◽  
Legal Regulation ◽  
Public Authorities ◽  
Public Control ◽  
The Russian Federation

The article is devoted to topical issues of determining the effectiveness of the work of governmental agencies in the Russian Federation. The relevance of the study’s subject matter is determined by the lack of comprehensive examination of the subject matter from the perspective of methodology and practice. Public authorities’ activities in the Russian Federation are changing acquiring new qualities. Thus, clear and uniform criteria for their assessment are necessary. Evaluation criteria should be closer to social indicators and should meet the demands of society. The author analyzes the normative-legal regulation of this issue. to this end, the paper provides examination of the Decrees of the President of the Russian Federation that have been issued since 2007 to establishing indicators for assessing the effectiveness of the activities of the executive authorities of the Russian Federation. It is possible to observe a constant change in the methodological approach to the number, formulation and content of the criteria for assessing the effectiveness of the executive authorities of the constituent entities of the Russian Federation. Between 2007 and 2012, the evaluation criteria were based on public control over the public services effectiveness exercised by citizens. Currently, the approach has changed — public control has been removed from the system under consideration and is now governed by a separate regulatory act. For the first time, to recognize executive authorities’ activities as effective the determination of the level of evaluation criteria to be met by executive authorities is used.The normative regulation of the evaluation of the effectiveness of the executive power at the federal level is also investigated. At the national level there is no any regulatory framework for assessing the activities of federal executive authorities of the Russian Federation. The author draws conclusions about the lack of a uniform approach to the evaluation of governmental authorities’ activities at both federal and regional levels. The conclusions can be used in law-making activities of state bodies.

scholarly journals Development of Common Approaches to the System of Indicators for Strategic Planning Documents of Russian Regions

2019 ◽  
pp. 56-65 ◽  
Author(s):  
Svetlana Lipina ◽  
Natalya Sorokina ◽  
Lyubov Belyaevskaya-Plotnik ◽  
Lina Bocharova
Keyword(s):  
Strategic Planning ◽  
Russian Federation ◽  
Methodological Approach ◽  
Continuous System ◽  
Government Programs ◽  
Legal Documents ◽  
Russian Region ◽  
The Social ◽  
The Russian Federation ◽  
The Government

The assessment of strategic planning documents at various levels of the system of state and municipal governance should allow not only to track the degree of achievement of planned results and the type of development of allocated resources but also to contribute to a fuller and completer understanding of the essence of processes and changes in the social and economic system of the territory (country, region, municipality). The methodological approach to the development of the system of indicators of government programs of a Russian region in relation with the indices from strategic documents of federal and regional levels is suggested. It is proved that the methodology of development of target indices of strategic papers of a region of the Russian Federation must be founded on a continuous system of coefficients and indices of strategic papers of various governance levels for the increase of assessment efficiency and obtaining the possibility of using the results for the assessment of their impact on the achievement of the goals set. Based on the analysis of the content of the federal legal documents (Order of the Ministry of Economic Development of the Russian Federation of September 16, 2016 No. 582 and Decree of the Government of the Russian Federation of August 2, 2010 No. 588), the main requirements for the indices (coefficients) for strategic papers of the regional level are specified. The specific measures and practical recommendations on the development of common approaches to the system of indices (coefficients) of government programs of regions of the Russian Federation in relation with indices (coefficients) of federal government programs and the indices (coefficients) developed by other regions are suggested.

scholarly journals MEDICINES: CONSTITUTIONAL AND LEGAL REGULATION ON RESTRICTION OF THE PROPERTY RIGHT CONCERNING TECHNOLOGY TRANSFER SUBJECTS AND THE RIGHT TO CONDUCT ENTREPRENEURSHIP ON IMPORT OF MEDICINAL PRODUCTS IN CONDITIONS OF CONFLICT AND TEMPORARY OCCUPATION

2021 ◽  
pp. 6-13
Author(s):  
Юрій Бисага
Keyword(s):  
Technology Transfer ◽  
Russian Federation ◽  
Legal Regulation ◽  
Democratic Society ◽  
Medicinal Products ◽  
Public Values ◽  
European Court ◽  
The Russian Federation ◽  
The Law ◽  
The Right

  The purpose of this article is to identify the features of restriction of ownership on the subjects of technology transfer regarding production of medicines and the right to run business on the import of medicines in conditions of conflict and temporary occupation. The methodological basis of the conducted research is the general methods of scientific cognitivism as well as concerning those used in legal science: methods of analysis and synthesis, formal logic, comparative law etc. When determining the legitimate purpose of restriction, it is necessary to apply the principle of proportionality, which is the concordance of measures applied to the above entities in order to limit the exercise of their rights with those public values that are protected by such restriction. On the procedural level, the State having realized the right for withdrawal has to comprehensively inform the General Secretary of the Council of Europe as for the measures taken and the reasons for them, as well as the time when those measures have ceased to apply and the provisions of the Convention are profoundly applied again. As the case law of the European Court of Human Rights shows, the derogation from the obligations under the Convention must have territorial and temporal specifications. The following features of the constitutional and legal regulation of restriction of property rights for subjects of technology transfer to the production of medicines are revealed: 1) restrictions on the implementation of these rights should be provided by the law, which must meet the following requirements: clarity, accuracy, accessibility; 2) the measure is a temporal one; 3) the range of entities in respect of which it is applied to are the subjects of technology transfer being residents of the aggressor country; 4) legitimate purpose of implementation is protection of public values (national security, life and health of persons staying on the territory of Ukraine, territorial integrity, etc.); 5) necessary in democratic society. The following features of the constitutional and legal regulation of restrictions on the right for running business activities regarding import of medicines during conflict and temporary occupation of the part of the territory of Ukraine by the Russian Federation are revealed: 1) restrictions on the exercise of these rights are provided by the Law of Ukraine “On Foreign Economic Activity” from 04.07.2017 №18.1-07/18369, which meets the following requirements: clarity, accuracy, accessibility; 2) the measure is temporal one; 3) the range of entities in respect of which it is applied to is addressed to the applicants of medicinal products, alternative and/or potential manufacturers, applicants-holders of registration certificates of which are the subjects of the Russian Federation; 4) legitimate purpose of implementation is protection of life and health of persons staying on the territory of Ukraine in connection with the impossibility of providing Ukraine with proper control over the quality of production of medicines within the Russian Federation; 5) necessary in democratic society.    

scholarly journals Implementing the personnel potential of the public civil service of a constituent entity of the Russian Federation in the context of the introduction of a comprehensive assessment of personnel

2021 ◽  
Vol 101 ◽  
pp. 02019
Author(s):  
Tatiana Alekseeva ◽  
Elena Bezvikonnaya ◽  
Aleksander Bogdashin ◽  
Elena Portnyagina
Keyword(s):  
Russian Federation ◽  
Public Service ◽  
Public Management ◽  
Methodological Approach ◽  
Federal District ◽  
Comprehensive Assessment ◽  
Civil Servants ◽  
Constituent Entity ◽  
The Russian Federation ◽  
Professional Evaluation

Under the conditions of administrative reform, implemented within the ideology of public management, the issues of assessing the effectiveness of the institution of public service turn out to be one of the systemic. The priority established by the state in favor of the introduction of key performance indicators (KPIs) in the professional evaluation of civil servants requires thinking about its impact on the formation of human resources capacity. The purpose of the article is to evaluate the mechanisms of implementation of a comprehensive assessment of the professional activities of civil servants in the constituent entity of the Russian Federation (based on the materials of the Omsk region). The methodological basis of the study is a systematic methodological approach and methods for assessing the personnel potential of public service. The novelty of the work lies in the involvement of the source base of the Omsk region as one of the typical regions of the Siberian Federal District. The results of the study are of particular value for the summarization of the practice of implementing the mechanism of comprehensive professional evaluation of civil servants in the constituent entities of the Russian Federation.

scholarly journals Prospects for Reducing Accidents on the Roads of the Russian Federation Using the Scientific and Methodological Approach

2021 ◽  
Vol 334 ◽  
pp. 01038
Author(s):  
Sergey Glagolev ◽  
Aleksander Novikov ◽  
Ivan Novikov ◽  
Anastasia Shevtsova
Keyword(s):  
Russian Federation ◽  
Traffic Safety ◽  
Traffic Accidents ◽  
Methodological Approach ◽  
Emergency Situation ◽  
Transport Systems ◽  
Intelligent Transport ◽  
Emergency Situations ◽  
Depth Analysis ◽  
The Russian Federation

This article reports the results of an in-depth analysis of the transport situation in the Russian Federation and presents the main programmes, aimed at its improvement. The paper deals with the major ways of reducing risk of traffic accidents and increasing traffic safety. The paper proposes the scientific and methodological approach, providing the specialists with the opportunities of conducting a comprehensive assessment of the causes of emergencies and aiming at eliminating road accidents rates. The origin of the process of an emergency situation occurrence has been investigated and designed, the key components (constituents) of the process have been identified and the basic mechanisms, influencing the basic components, have been analyzed. The algorithm of the application of the proposed and developed scientific and methodological approach at the level of departmental organizations has been suggested. The article describes the mathematical model of the process of emergency situations occurrence, which, together with the applied telematics systems and intelligent transport systems, will help to achieve the basic objectives of the study.

scholarly journals DIFFERENTIATION OF THE REGIONS OF THE CENTRAL FEDERAL DISTRICT OF THE RUSSIAN FEDERATION ACCORDING TO THE LEVEL OF COMPETITIVE ADVANTAGES

2019 ◽  
Vol 7 (5) ◽  
pp. 835-839
Author(s):  
Larisa A. Tretyakovа ◽  
Marina V. Vladyka ◽  
Tatyana A. Vlasova ◽  
Denis S. Glotov
Keyword(s):  
Russian Federation ◽  
Methodological Approach ◽  
Federal District ◽  
Economic Systems ◽  
Competitive Advantages ◽  
Target Groups ◽  
Central Federal District ◽  
Teachers And Students ◽  
The Russian Federation ◽  
Further Development

initial key competitive indicators, including those reflecting the regional resource potential. Methodology: The usage of the proposed methodological approach provides model systematization of data based on selected indicators of competitiveness, reflecting the effectiveness of socio-economic processes in the development of regional space and indicators of resource provision in the region, determining the development of competitive advantages. Result: The most important condition for ensuring the sustainability of socio-economic systems is competitiveness. The processes of globalization have increased attention not only to the cross-country component of competitiveness but also to the formation, evaluation, and development of the competitive advantages of individual regions. Due to the fact that it is the complex of various competitive advantages of a region that predetermines its competitive position among other regions and provides attractiveness in the context of the main target groups whose inflow the region needs for further development, it becomes very important to compare competitive advantages based on their quantitative and qualitative measurement. Applications: This research can be used for universities, teachers, and students. Novelty/Originality: In this research, the model of Differentiation of the Regions of the Central Federal District of the Russian Federation According to the Level of Competitive Advantages is presented in a comprehensive and complete manner.

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