Biosimilars: evolution of approaches to the development, regulation, life cycle control and interchangeability management

2021 ◽  
pp. 56-68
Author(s):  
Ravil R. Niyazov ◽  
Margarita A. Dranitsyna ◽  
Andrey N. Vasiliev ◽  
Elena V. Gavrishina
Keyword(s):  
Active Substance ◽  
Legal Framework ◽  
Development Stage ◽  
Clear Understanding ◽  
The European Union ◽  
Functional Tests ◽  
Pharmacological Studies ◽  
The Usa ◽  
Development Regulation ◽  
Single Approach

The legal framework for biosimilar medicinal product was first established in 2004 in the European Union and later in the USA. Since then, based on the scientific and regulatory experience with biosimilarity assessment, regulatory approaches have evolved considerably. A clear understanding of the capabilities of each development stage in assessing comparability in terms of power to identify differences and assess their relevance to the final clinical outcome gradually accumulated. In addition to the commitment to the biosimilarity approach, it is important to comply with the general requirements applicable to any drugs produced at an industrial scale. Experience showed that the demonstration of biosimilarity based on a range of analytical and functional tests and mainly clinical pharmacological studies is universal and allows extrapolating therapeutic indications. The establishment of biosimilar interchangeability, since the active substance by definition is a version of the active substance of the corresponding reference biological product, can introduce additional difficulties. A single approach to the establishment of biosimilar interchangeability has not yet been developed.

scholarly journals FOREIGN EXPERIENCE IN ELECTRONIC TAX ADMINISTRATION AND THE POSSIBILITIES OF ITS USE IN UKRAINE

2019 ◽  
Vol 4 (5) ◽  
pp. 240
Author(s):  
Nataliia Ortynska ◽  
Liudmyla Savranchuk ◽  
Svitlana Matchuk
Keyword(s):  
Legal Framework ◽  
Tax Administration ◽  
The European Union ◽  
Legal Doctrine ◽  
Scientific Methods ◽  
Foreign Experience ◽  
Foreign Countries ◽  
Domestic Legislation ◽  
Effective System ◽  
The Usa

The aim of the article is to study the foreign experience of electronic tax administration on the basis of the analysis of scientific literature, and as well as to determine the possibilities for its use with further improvements of domestic legislation in this field in Ukraine. The subject of the study is the foreign experience of electronic tax administration and the possibility of its use in Ukraine. Methodology. The research is based on the dialectical method of scientific knowledge and on general scientific methods, which are based on it, such as: analysis, comparison, analogy, induction, and others. Results of the conducted study have shown that today there is a large number of countries where the digital tax format functions effectively and constantly develop. It is substantiated that the use of the experience provided in the article will give an opportunity to build a simple and effective system of electronic tax administration in Ukraine. And this fact, of course, will influence positively on the financial sphere in Ukraine. Practical impact. The positive experience of establishing a legal framework for the provision of electronic tax administration in foreign countries proves that the digital tax format functions effectively and is constantly developing. Besides, some practices of these countries in the field of electronic tax administration can be rather positive for implementation in the territory of Ukraine. Correlation/originality. Conducting a comparative analysis of the legislation and legal doctrine of Ukraine, and the countries of the European Union and the USA regarding the legal provision of electronic tax administration is the basis for developing the most promising directions of development of domestic legislation in the financial sector of the entire Ukrainian state.

scholarly journals Mechanisms for Innovative-Driven Solutions in European Smart Cities

Smart Cities ◽  
2020 ◽  
Vol 3 (2) ◽  
pp. 527-540 ◽  
Author(s):  
Stella Manika
Keyword(s):  
Smart Cities ◽  
Public Procurement ◽  
Legal Framework ◽  
Development Stage ◽  
Life Cycle Approach ◽  
The European Union ◽  
Public Authorities ◽  
European Public ◽  
Legislative Framework ◽  
Broad Objective

Innovative procurement is an important tool for smart cities to improve the effectiveness and efficiency of public services, especially in sectors such as smart living (for example, health conditions), smart mobility, or smart environment (with emphasis on waste and water management). The European Union (EU) public procurement legislative framework encourages the deployment of innovation by several means (including, inter alia, the introduction of competitive procedures promoting innovation, use of award criteria based on factors other than price, and the life-cycle approach) and sets the scene for a more strategic procurement for EU smart cities. Despite the proven benefits of innovative procurement, public authorities, driven mainly by their preference to follow traditional tender procedures under solely budgetary considerations, have hesitated to introduce innovation. The case study of Greece is examined, and it is concluded that despite the adopted policy measures that are conducive for mainstreaming innovation procurement, innovation procurement in Greece is at an early development stage. One of the reasons that hinder the application of innovation-oriented procedures by public purchasers is their insufficient knowledge of the available legal framework. The broad objective of this article is to outline the main innovation-friendly tools, as set out in the applicable European public procurement legislative framework that smart cities should adopt in order to make strategic use of innovative procurement.

scholarly journals Vocational Training of Future Agricultural Specialists: European Experience

2018 ◽  
Vol 8 (2) ◽  
pp. 160-165
Author(s):  
Vitalii Barbinov
Keyword(s):  
European Union ◽  
Agricultural Education ◽  
Vocational Training ◽  
Agricultural Sector ◽  
Legal Framework ◽  
Full Time ◽  
The European Union ◽  
European Experience ◽  
Low Incomes ◽  
The Usa

AbstractThe article focuses on vocational training of future agricultural specialists in the context of European experience. Thus, theoretical framework of the research has been thoroughly justified. It includes the prominent documents of European authorities such as the Charter of European Agricultural Education, CAP context indicators for 2014–2020, European Parliament’s publications, Eurostat statistics such glossary of farmers training level terms, as well as respected researches of many European scholars (A. Miceli, A. Moore, M. Mulder et al.). It has been found that European approach to organizing vocational training of future agricultural specialists is rather multiaspect and strives to fulfill educational needs of majority of learners, namely, through practical agricultural training, basic agricultural training and full-time agricultural trainings. It has been clarified that more and more young people realize the importance of the agricultural sector to the overall prosperity of the European Union; therefore they seek quality vocational training based on relevant vocational schools. It has been stated that European Union constantly develops various strategies for developing the agricultural sector, in particular through enhancing quality of future agricultural specialists’ vocational training. It has been defined that despite the fact that low incomes, certain risks, uncertainties in an economic environment due to globalization processes may somehow discourage younger generations to pursue career in agriculture, the CA implements different mechanisms for sustaining stable development of agricultural education. It has been specified that such countries as France and Germany regularly update the content of agricultural education so that it takes into account the trends in vocational training of future agricultural specialists opportunity and allows applying the most advanced teaching technologies, promoting knowledge significance, widening access to all levels of education, implementing a system of lifelong learning, individualizing agricultural education. It has been outlined that the prospects for further studies are seen in studying the most important aspects in the legal framework of the agricultural education system in innovative experience of European countries, the USA, Canada, Australia, etc.

Determinants and barriers of PV self-consumption in Spain from the perception of the installers for the promotion of distributed energy systems

2020 ◽  
pp. 153-169
Author(s):  
José Ángel Gimeno ◽  
Eva Llera Sastresa ◽  
Sabina Scarpellini
Keyword(s):  
European Union ◽  
Energy Transition ◽  
Legal Framework ◽  
Low Carbon ◽  
The European Union ◽  
Distributed Energy ◽  
Sustainable Solutions ◽  
Highly Sensitive ◽  
Transition Scenario

Currently, self-consumption and distributed energy facilities are considered as viable and sustainable solutions in the energy transition scenario within the European Union. In a low carbon society, the exploitation of renewables for self-consumption is closely tied to the energy market at the territorial level, in search of a compromise between competitiveness and the sustainable exploitation of resources. Investments in these facilities are highly sensitive to the existence of favourable conditions at the territorial level, and the energy policies adopted in the European Union have contributed positively to the distributed renewables development and the reduction of their costs in the last decade. However, the number of the installed facilities is uneven in the European Countries and those factors that are more determinant for the investments in self-consumption are still under investigation. In this scenario, this paper presents the main results obtained through the analysis of the determinants in self-consumption investments from a case study in Spain, where the penetration of this type of facilities is being less relevant than in other countries. As a novelty of this study, the main influential drivers and barriers in self-consumption are classified and analysed from the installers' perspective. On the basis of the information obtained from the installers involved in the installation of these facilities, incentives and barriers are analysed within the existing legal framework and the potential specific lines of the promotion for the effective deployment of self-consumption in an energy transition scenario.

9/11 and Armageddon: the Christian Right and George W. Bush

2003 ◽  
Vol 2 (1) ◽  
pp. 33-50
Author(s):  
Göran Gunner
Keyword(s):  
New York ◽  
Christian Right ◽  
Political Life ◽  
Religious Leader ◽  
The European Union ◽  
The World ◽  
Mega Church ◽  
The Usa ◽  
Jerry Falwell ◽  
High Degree

Authors from the Christian Right in the USA situate the September 11 attack on New York and Washington within God's intentions to bring America into the divine schedule for the end of the world. This is true of Pat Robertson and Jerry Falwell, and other leading figures in the ‘Christian Coalition’. This article analyses how Christian fundamentalists assess the roles of the USA, the State of Israel, Islam, Iraq, the European Union and Russia within what they perceive to be the divine plan for the future of the world, especially against the background of ‘9/11’. It argues that the ideas of the Christian Right and of President George W. Bush coalesce to a high degree. Whereas before 9/11 many American mega-church preachers had aspirations to direct political life, after the events of that day the President assumes some of the roles of a mega-religious leader.

Corporate culture as a driver of the corporate security of foreign military-industrial enterprises

2020 ◽  
Vol 16 (12) ◽  
pp. 2363-2380
Author(s):  
S.B. Zainullin ◽  
O.A. Zainullina
Keyword(s):  
Corporate Culture ◽  
Economic Security ◽  
The State ◽  
Industrial Complex ◽  
The European Union ◽  
Corporate Security ◽  
Industrial Enterprises ◽  
The Core ◽  
The Usa ◽  
The Military

Subject. The military-industrial complex is one of the core industries in any economy. It ensures both the economic and global security of the State. However, the economic security of MIC enterprises strongly depends on the State and other stakeholders. Objectives. We examine key factors of corporate culture in terms of theoretical and practical aspects. The article identifies the best implementation of corporate culture that has a positive effect on the corporate security in the MIC of the USA, the United Kingdom, the European Union, Japan ans China. Methods. The study employs dialectical method of research, combines the historical and logic unity, structural analysis, traditional techniques of economic analysis and synthesis. Results. We performed the comparative analysis of corporate culture models and examined how they are used by the MIC corporations with respect to international distinctions. Conclusions and Relevance. The State is the main stakeholder of the MIC corporations, since it acts as the core customer represented by the military department. It regulates and controls operations. The State is often a major shareholder of such corporations. Employees are also important stakeholders. Hence, trying to satisfy stakeholders' needs by developing the corporate culture, corporations mitigate their key risks and enhance their corporate security.

Russian Federation and the United States of America: geostrategic directions to manage the Ukrainian crisis

2019 ◽  
pp. 123
Author(s):  
Attarid Awadh Abdulhameed
Keyword(s):  
United States ◽  
European Union ◽  
National Security ◽  
Russian Federation ◽  
United States Of America ◽  
The United States ◽  
The European Union ◽  
The Usa ◽  
Ukrainian Crisis ◽  
Zero Sum

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers.  As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to  Russians national Security and its independent role and in funence  on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.

Characteristics of international business development between ukraine and poland

2019 ◽  
pp. 28-35
Author(s):  
Viktoriia Makhovka ◽  
Olha Nesterenko
Keyword(s):  
European Union ◽  
Small Business ◽  
International Business ◽  
Legal Framework ◽  
Strategic Partnership ◽  
Economic Systems ◽  
The European Union ◽  
Doing Business ◽  
Modern Development ◽  
Trade And Investment

The essence of international business, its active development and expansion, that influence the integration of economic systems and intensification of business relations between countries, are considered. The attention is paid to the international market of the European Union, first of all to Polish-Ukrainian cooperation due to the modern development of international business. The importance of the development of trade and business between Ukraine and Poland is determined, taking into account close relations in the field of economy, politics, culture and historical connections. The legal framework between Ukraine and Poland is substantiated, which ensures the proper development of bilateral cooperation at the level of strategic partnership and emphasizes the presence of an active dialogue between countries. The main agreements between Ukraine and the European Union, which influence the economic cooperation between Ukraine and Poland, are considered, taking into account Polish membership in the EU. The implementation of special projects by the European Union to support the development of Polish-Ukrainian cooperation is determined. The increase of the intensity of economic exchange between Ukraine and Poland, the active development of trade and investment in various spheres of business and the growth of economic indicators are determined. The peculiarities of the development of the small business sector and its influence on the stabilization of socio-economic processes between European countries are substantiated, emphasizing Poland's experience in development of the small business as a driving force on the way to economic integration. The main aspects and characteristics of international business between Poland and Ukraine are determined and the main differences in doing business in these countries are revealed, emphasizing the perspectives of development.

EXPERIENCE, PROSPECTS AND PROBLEMS OF COOPERATION BETWEEN CHINA AND TURKMENISTAN IN THE FIELDOF NATURAL GAS

2019 ◽  
pp. 323-329
Author(s):  
Y. JIA
Keyword(s):  
Natural Gas ◽  
Central Asia ◽  
Oil And Gas ◽  
The European Union ◽  
Multilateral Cooperation ◽  
Industrial Chain ◽  
The Usa ◽  
Gas Consumption ◽  
Slow Progress ◽  
Natural Gas Consumption

Since 2007, the use of natural gas in China depends on the import, and with an increase in natural gas consumption, gas imports are also constantly growing. In 2018, Chinas natural gas imports approached 100 billion cubic meters, which is 70 times more than in 2006. In recent years, increasing attention has been paid to the use of natural gas in China. Turkmenistan is Chinas main source of pipeline gas imports, and China is Turkmenistans largest exporter of natural gas. In the framework of the traditional model of oil and gas cooperation, China and Turkmenistan are facing such problems as the uniform content of cooperation, lack of close ties in the field of multilateral cooperation and slow progress in the development of the entire industrial chain. Cooperation between China and Central Asia in the field of oil and gas is increasingly affecting the nerves of other countries, except the five countries of Central Asia, but including Russia, Afghanistan, Pakistan, India, Iran and other countries of the Middle East, Japan, South Korea, etc. and even the European Union and the USA. Despite the favorable trading environment for both parties, there are also problems in the domestic market of Turkmenistan and the risks of international competition.

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