scholarly journals Comparative Analysis of Approaches to Assess the Quality of Inactivated Influenza Vaccines: Regulatory Requirements in the Russian Federation and European Union

2021 ◽  
Vol 19 (6) ◽  
pp. 36-47
Author(s):  
L. M. Khantimirova ◽  
S. G. Guseva ◽  
V. A. Shevtsov ◽  
V. A. Merkulov ◽  
V. P. Bondarev
Keyword(s):  
European Union ◽  
Comparative Analysis ◽  
Russian Federation ◽  
Influenza Vaccines ◽  
Alternative Methods ◽  
Regulatory Requirements ◽  
Influenza Prevention ◽  
The Russian Federation ◽  
The Eu

The experience with the influenza pandemic caused by strain A (H1N1) 2009 and the existing gaps in standardizing and evaluating the quality and effectiveness of vaccines for influenza prevention have led the European Union (EU) to recognize the need to review / update the current guidelines on requirements for the development, quality, and preclinical and clinical research. In February 2018 Guideline on influenza vaccines -quality module (EMA/CHMP/BWP/310834/2012 Rev.l) came Into effect In the EU countries. The formation of the Eurasian Economic Union (EAEU) and the creation of a single market for pharmaceutical products entails the need to amend the current and the formation of new legislation, as well as changes in the rules and regulations regarding the pharmaceutical circulation processes in the Russian Federation: development, quality assurance in preclinical and clinical trials, monitoring the safety of medicines for medical use, in this regard, it seems appropriate to develop scientific and technical guidelines that are harmonized with international standards and approaches in the pharmaceutical field. The aim of the review was to conduct a comparative analysis of approaches to assessing the quality of vaccines for prevention influenza based regulatory requirements in the Russian Federation and European Union. Conclusion. In this article discusses the features of the requirements for the development and quality control of inactivated influenza vaccines in the Russian Federation and the EU. The article provides a comparative analysis of the requirements of the State Pharmacopoeia of the Russian Federation and the European Pharmacopoeia for quality indicators, which should be included in the regulatory documentation when registering the vaccine. The main changes in the EMA document «Guidelines for influenza vaccines - Quality module» consist of new approaches to standardizing vaccines for influenza prevention, in particular, determining the specific activity of inactivated influenza vaccines using adequate alternative methods and studying biological, immunological and physicochemical characteristics HA antigen using a wide range method. The results of the analysis of approaches to assessing the quality of vaccines for influenza prevention can be useful in developing harmonized with international norms and approaches scientific and technical guidelines in the pharmaceutical field. 

scholarly journals POTENTIAL AND ROLE OF UNDERSERVED FOREIGN MARKETS FOR THE DEVELOPMENT OF UKRAINE’S TRADE WITH THE EU

2020 ◽  
pp. 62-71
Author(s):  
O. Shnyrkov ◽  
D. Pliushch
Keyword(s):  
European Union ◽  
Russian Federation ◽  
Free Trade Area ◽  
The European Union ◽  
Foreign Markets ◽  
International Partnership ◽  
Trade Relations ◽  
Long Run ◽  
The Russian Federation ◽  
The Eu

The article identifies the volume of underserved markets for the development of Ukraine's foreign trade with the EU. The Ukraine's export potential on the EU underserved market is analyzed. It is established that the intensification of trade relations between the Ukraine and EU is a mutually beneficial process, and export potential of Ukraine in the EU market for goods whose exports to the Russian Federation have decreased is of particular importance. The main foreign markets of Ukraine for the export of agricultural and industrial goods from Ukraine have been identified. The main commodity groups of underserved markets to the EU have been identified, the exports of which to the Russian Federation have decreased the most. According to the results of the study, it has been concluded that the underserved markets of the European Union play an important role in the development of Ukraine's trade: first, they allow reorientation of exports of Ukrainian goods, the import of which is prohibited into the customs territory of the Russian Federation, to EU markets; secondly, they help to identify directions for the modernization of Ukrainian production in accordance with the unmet needs of the European goods market. It is concluded that the process of deepening mutual trade in underserved markets in a free trade area is mutually beneficial for Ukraine and the European Union, as trading partners can benefit from increased trade flows, and establishing international partnership between the parties can bring additional benefits in the long run.

scholarly journals Development of legislation on environmental insurance: experience of the European Union and Russia

2021 ◽  
Vol 7 (3) ◽  
pp. 155-160
Author(s):  
Vladimir S. Sinenko ◽  
Evgeniy E. Tonkov ◽  
Sergey A. Belousov ◽  
Irina S. Iskevich ◽  
Angelina V. Petergova
Keyword(s):  
European Union ◽  
Russian Federation ◽  
Environmental Responsibility ◽  
Environmental Damage ◽  
Natural Resource Policy ◽  
The European Union ◽  
Priority Direction ◽  
Resource Policy ◽  
The Russian Federation ◽  
The Eu

This article analyzes the development of the environmental insurance legislation of the European Union and the Russian Federation. The advantages of this mechanism in matters of compensation for harm caused to the environment due to environmental offenses are determined. The analysis of Directive No. 2004/35 / CE of the European Parliament and the Council of the EU on environmental responsibility, aimed at preventing environmental damage and eliminating its consequences. A comparison of Russian legislation with the norms of environmental insurance adopted in the European Union is carried out. The conclusion is formulated that environmental insurance should become a priority direction of the state natural resource policy.

scholarly journals INDICATORS OF THE ACTIVITIES OF THE CUSTOMS BODIES OF THE RUSSIAN FEDERATION IN THE CONTEXT OF IMPLEMENTING THE CONCEPT "TEN STEPS TOWARDS BUSINESS"

2018 ◽  
pp. 12-16 ◽  
Author(s):  
A. D. Skudarnova ◽  
D. D. Razhivina
Keyword(s):  
Comparative Analysis ◽  
Russian Federation ◽  
Economic Activity ◽  
Information Technologies ◽  
The Road ◽  
Road Map ◽  
The Russian Federation ◽  
Modern Information ◽  
Key Indicators

The article is devoted to the problems of interaction between customs authorities and participants in foreign economic activity, ways of developing the customs system and supporting business through the introduction of modern information technologies, a comparative analysis of key indicators of assessing the quality of customs services in accordance with the road map " 10 steps towards the business "and the indicators presented in the existing system for assessing the performance of customs bodies of Russia Federation.

scholarly journals EU–Russia Security Cooperation

2020 ◽  
Vol 6 (3) ◽  
pp. 123-130
Author(s):  
M.I. Yanin ◽  
◽  
D.S. Bunevich ◽  
◽  
Keyword(s):  
European Union ◽  
Russian Federation ◽  
Political Crisis ◽  
The European Union ◽  
Security Cooperation ◽  
European Continent ◽  
Mutual Interest ◽  
The Russian Federation ◽  
Political Realities ◽  
The Eu

at present, relations between the Russian Federation and the European Union are in a state of political crisis. The existing disagreements negatively affect the relations of two international players on the European continent. The article discusses the areas of interaction between the Russian Federation and the EU in the field of security, which, contrary to modern political difficulties, reflect the mutual interest of the parties. The author concludes that the joint approaches of Russia and the European Union to resolving issues related to security are a stabilizing factor in the formation of the EU–Russia dialogue in modern political realities.

scholarly journals An Analysis of the EU Experience in Constructing a System of Controller Relationships with MFIs in the Field of AML / CFT and its Application in the Russian Federation

2018 ◽  
Vol 3 (2) ◽  
pp. 15
Author(s):  
M. Bogdanova ◽  
E. Gorshkov ◽  
N. Kabanova
Keyword(s):  
Comparative Analysis ◽  
Interest Rates ◽  
Russian Federation ◽  
Downward Trend ◽  
Rf System ◽  
The Russian Federation ◽  
Financing Of Terrorism ◽  
The Moment ◽  
Primary Measure ◽  
The Eu

The article deals with the experience of regulating the issues of countering the laundering (legalization) of proceeds from crime and financing of terrorism (hereinafter AML / CFT) in microfinance organizations (hereinafter referred to as MFIs) using the example of the EU. The downward trend in the MFI market in Russia is largely due to the violation of AML / CFT legislation. In this connection, there arises the problem of regulating MFIs in this field. A comparative analysis of the system of relations between MFIs and the regulator in the Russian Federation and the EU allows us to conclude that it is impossible to apply the EU experience in the RF system at the moment. The primary measure is to revise interest rates used by MFIs to approach the understanding of MFIs in the EU. Keywords: microfinance organization, AML / CFT, EU experience, regulator.

scholarly journals Interaction of Party Structures of The EU and the Russian Federation in a Discourse of the Russian Left Forces on the Example of “A Just Russia” Party

2019 ◽  
Vol 9 (4) ◽  
pp. 83-87
Author(s):  
S. P. Mitrakhovich
Keyword(s):  
European Union ◽  
Identity Politics ◽  
Russian Federation ◽  
European Parliament ◽  
The European Union ◽  
Political Processes ◽  
Political Forces ◽  
Party Elites ◽  
The Russian Federation ◽  
The Eu

The article using “A Just Russia” case deals with the party strategies of the Russian left political forces for the creation of the relations with party structures of the European Union. Similar party strategy is at the same time a part of domestic policy and development of the Russian political processes, and at the same time, they are a part of the relationship with the European Union which is built up by Russia. Consequently, that is de facto a part of foreign policy activity. The novelty of the research consists in a combination of the research approaches used in a “partology” while considering a party to be a rational actor acting in conditions of a country political environment and the research approaches accepted in modern European studies. Parties act as internal political players, but at the same time and as contractors of foreign elite, in this case — party elite of the European Union, members of party groups of European Parliament, party Internationals, “the European parties” (earlier known under the term of “party at the European level”). From the Russian parliamentary political forces of several last electoral cycles “A Just Russia”, using a discourse of modern socialism, could establish more actively than others cooperation with European left, including influencing adoption of significant decisions in the EU, for example, on reform of the EU Gas Directive and the Third Energy Package of the EU. The party, through the prism of socialist ideology, is trying to bring together certain positions of the party elites of the Russian Federation and the EU, bringing differences on social avant-garde and identity politics out of the brackets. Therefore, it focuses recently on the problems of sanctions issues, considering its communication with the Party of European socialists and socialist groups in the European Parliament as another potentially popular diplomatic track for the country.

scholarly journals Germany and the European Union After the Epoch of Chancellor Angela Merkel

2021 ◽  
Vol 65 (9) ◽  
pp. 43-55
Author(s):  
V. Vasil'ev
Keyword(s):  
European Union ◽  
Russian Federation ◽  
Focal Point ◽  
Technological Development ◽  
World Order ◽  
Federal Republic Of Germany ◽  
The European Union ◽  
Angela Merkel ◽  
The Russian Federation ◽  
The Eu

The article is devoted to the analysis of the political legacy of German Chancellor Angela Merkel and in what way the new German government might possibly use it dealing with the transformation of the country and modernization of the European Union. The new political coalition with possible participation of the Green Party will preserve the continuity of the German foreign policy course for strengthening the European Union, deepening the transatlantic partnership, for active cooperation between Berlin and Paris, as well as for inclusion of Belarus, Moldova and Ukraine into the Euro-Atlantic area. The European sovereignty is the main focal point in Berlin. The Conference on the Future of Europe examines it, as well as other evolution issues. The updated legal framework of the EU, feasible strengthening of the European Parliament positions could help transform the European Union into a weighty actor in the polycentric world. Only powerful, relatively sovereign EU is able to secure the “European way of life”. Judgments about the disintegration of the European Union are far from reality. The EU margin of safety and resistance are quite impressive, primarily due to the economic potential of Germany. However, it is really difficult to predict how the European Union will get out of the crisis caused by Covid 19. American concessions to the Germans on the Nord Stream 2 project mean Biden’s serious attitude towards Merkel and Germany – the leader in the EU and one of the important NATO allies. The conditions for Russia’s return to the “European club”, for example, through the revival of M. Gorbachev’s new political thinking in Moscow, indicate rather an illusory desire. There is another, more pragmatic approach. The single European cultural and historical matrix of Greater Europe, communication between the leaders of the Russian Federation, Germany, France and the USA, the economic foundation of contacts, as well as mutual sympathies between Russians, Germans, Europeans give reason to hope for a turn for the better. The chances of a unification agenda remain. Perhaps, it will be used by future generations of politicians, experts of the Russian Federation and the Federal Republic of Germany without preconditions, on the basis of reasonable compromises. Acknowledgements. The article was prepared within the project “Post-Crisis World Order: Challenges and Technologies, Competition and Cooperation” supported by the grant from Ministry of Science and Higher Education of the Russian Federation program for research projects in priority areas of scientific and technological development (Agreement 075-15-2020-783).

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