scholarly journals Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Viviana Giannuzzi ◽  
Mariagrazia Felisi ◽  
Donato Bonifazi ◽  
Hugo Devlieger ◽  
George Papanikolaou ◽  
...  
Keyword(s):  
European Union ◽  
Descriptive Analysis ◽  
Ethics Committees ◽  
Paediatric Population ◽  
European Countries ◽  
The European Union ◽  
Clinical Trial Application ◽  
Paediatric Trial ◽  
General Linear Model Analysis ◽  
The Impact

Abstract Background We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases. Result The authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries. Conclusion This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

scholarly journals Ethical and Procedural Issues For Applying Researcher-Driven Multi-National Paediatric Clinical Trials in and Outside The European Union: The Challenging Experience of The DEEP Project

2021 ◽  
Author(s):  
Viviana Giannuzzi ◽  
Mariagrazia Felisi ◽  
Donato Bonifazi ◽  
Hugo Devlieger ◽  
George Papanikolaou ◽  
...  
Keyword(s):  
European Union ◽  
Ethics Committees ◽  
Paediatric Population ◽  
European Countries ◽  
The European Union ◽  
Clinical Trial Application ◽  
Paediatric Trial ◽  
General Linear Model Analysis ◽  
Wilcoxon Rank Sum Test ◽  
The Impact

Abstract Background. We describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512).This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were evaluated.Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.Result. The authorisation process was completed in 7,7 to 53,8 months in European countries and in 17,1 to 27,1 months in non-European countries. The main factors influencing these timelines resulted the requests for changes/clarifications in European countries and the different national legislations in non-European countries.Conclusion. This work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-EU countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/CAs. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort.

scholarly journals International legal experience in combating illegal migration by sea

2021 ◽  
Vol 66 ◽  
pp. 284-287
Author(s):  
O.O. Kukshynova ◽  
A. O. Samoilenko
Keyword(s):  
European Union ◽  
Legal Framework ◽  
Legal Regulation ◽  
European Countries ◽  
The European Union ◽  
Illegal Migration ◽  
Illegal Migrants ◽  
Theoretical Approaches ◽  
The Impact ◽  
Treaty Of Amsterdam

This article highlights the impact of international law on the global process of illegal migration, reveals a number of international problems related to international migration, in particular by sea, identifies the main factors influencing illegal migration in general, indicates the state of illegal migration in various European Union countries. attention is paid to such important international legal instruments as the Schengen Agreement of 1985 and 1990, the Dublin Convention of 1990, the Maastricht Treaty of 1992 and the Treaty of Amsterdam of 1997. The article also focuses on the European Union agency, which deals with the protection of external borders and their protection from illegal migrants, in particular, by sea.The analysis of theoretical and practical aspects of combating illegal migration by sea at the international level, as well as in the development of scientific and theoretical approaches to solving migration problems, characterizes the legal regulation of combating illegal migration by maritime transport and maritime participation established intergovernmental bodies. The main tools of the European Union to combat illegal migration by sea, which can be used to improve the legal regulation of migration authorities of other countries, as well as substantiate the organizational and legal framework of European countries in the field of legal support to combat illegal migration by sea.The actions of European states represented by the relevant state bodies in solving the problems of illegal migration with the help of merchant fleets of European countries are studied. The article pays attention to the influence of illegal migration on the formation and change of legal awareness of society, as the beginning of the formation of criminogenic factors among illegal migrants in the host country.

14. European Politics into the Future

2021 ◽  
pp. 256-269
Author(s):  
Catherine E. De Vries ◽  
Sara B. Hobolt ◽  
Sven-Oliver Proksch ◽  
Jonathan B. Slapin
Keyword(s):  
European Union ◽  
Eastern Europe ◽  
European Countries ◽  
European Politics ◽  
Democratic Deficit ◽  
The European Union ◽  
The United Kingdom ◽  
European Democracy ◽  
The Future ◽  
The Impact

This chapter explores recent changes in European politics and looks to the future for European democracy as it stands now. The chapter explores the ongoing political change that can be seen within European countries and also at the European Union (EU) level. It aims to highlight four important debates about the state of democracy in Europe. These are: the debates about the rise of political fragmentation and its consequences for democracy; democratic backsliding in central and eastern Europe; the impact of the United Kingdom leaving the EU on democracy; and the democratic deficit in EU politics.

scholarly journals The reality of Palestinian-European trade relations: العلاقات التجارية الفلسطينية الأوروبية الواقع والشراكة

2015 ◽  
Vol 1 (3) ◽  
Author(s):  
Akram Fares Mohammed Abu Jameh
Keyword(s):  
European Union ◽  
Descriptive Analysis ◽  
The European Union ◽  
Economic Sectors ◽  
Commercial Activity ◽  
European Economic ◽  
Trade Relations ◽  
Palestinian Territories ◽  
European Trade ◽  
The Impact

This study aims at unveiling the reality of Palestinian-European trade relations and at identifying the mechanisms and programs pursued by the European Union to support Palestinian territories. This research studies the impact on economic sectors, productive activities and the access to European trade support for Palestinians by identifying the behavior and the nature of relations between the two sides and the extent of its development. The study revealed the reality of the Palestinian European Economic Partnership and the most important items that express the priority given to Palestine.  The research manipulates the descriptive analysis approach, it shows the size and nature of changes in the foreign Palestinian trade with the European Union during the period from 1994 until 2014. It makes use of the latest studies, ideas, previous literature analysis, reports and statistics issued in this area to enrich the study. The study revealed some significant findings: the period in which commercial exchange rate is at best came in line with the availability of an appropriate atmosphere and political optimism. Despite the improved performance of the European support, the Israeli siege and enormous losses of the Palestinian economy might explain the noticeable deceleration in the economic growth rates of the last years.  The results unveiled also that the agreements, lines of donations, mechanisms of cooperation, the European Neighborhood agreement. are still below the required level due to the Israeli arbitrary measures, particularly with regard to restricted commercial activity. And this is not consistent with the hypothesis that the Palestinian-European partnership agreement is the only influential item in Palestinian-European economic relations.

scholarly journals The impact of COVID-19 pandemic on the volume of labor migration, employment, and remittances

2021 ◽  
Vol 71 (2) ◽  
pp. 195-202
Author(s):  
Olha Podra ◽  
Nataliia Petryshyn ◽  
Oksana Bayik ◽  
Ulyana Bobko ◽  
Halyna Levkiv
Keyword(s):  
Economic Growth ◽  
European Union ◽  
Labor Migration ◽  
Systematic Approach ◽  
European Countries ◽  
The European Union ◽  
Labor Migrants ◽  
Political Situation ◽  
The Impact ◽  
Critical Methods

Flows of external labor migration in most cases occur under the influence of the internal economic and political situation in the country; however, in 2020 these trends changed significantly for reasons which did not depend on the socio-economic situation. In order to determine the volume of labor migration in 2020, an analysis was conducted. According to the results, it has been concluded that, despite the restrictive quarantine measures implemented in the European Union (EU) that caused the partial return of migrants to their countries, the rise in unemployment and slow economic growth, labor migrants are highly employed in key occupations of EU that are vital in the fight against coronavirus disease (COVID-19). It has been noticed that EU countries increase the number of officially issued residence permits to citizens of non-member countries every year, and Ukraine has become the absolute leader in the number of received residence permits, as well as the leader among European countries by the volume of the received remittances. An abstract-logical and systematic approach, analytical, comparative, graphical, and critical methods were used in the study. Prospects for external labor migration of Ukrainians to European countries have been identified.

scholarly journals Human Capital in Digital Economy: An Empirical Analysis of Central and Eastern European Countries from the European Union

2021 ◽  
Vol 13 (4) ◽  
pp. 2020
Author(s):  
Adriana Grigorescu ◽  
Elena Pelinescu ◽  
Amalia Elena Ion ◽  
Monica Florica Dutcas
Keyword(s):  
European Union ◽  
Human Capital ◽  
Global Economy ◽  
Fixed Effects ◽  
European Countries ◽  
Eastern European ◽  
The European Union ◽  
Technology Talent ◽  
Eastern European Countries ◽  
The Impact

The hypercompetitive global economy of the 21st century is a hub of innovation, technology, talent, skills, speed, efficiency, productivity, and satisfaction. Within this context, the organizations are looking intensely for people with skills and talents that can differentiate themselves in all that noise. The human capital became slowly but surely a mean of efficiency and growth, especially through the premises of digitization, and a key issue of sustainability. The current research is meant to identify and highlight any correlations that might appear between the population’s welfare of 11 Central and Eastern European Countries (CEECs) which are members of the European Union (EU), and the components of the digitization trend, including the new human cloud industry, ICT, and the connectivity to the Internet of Things. In order to achieve the needed insights, the multiple regression analysis was employed, and the latter tested the panel models with fixed effects, both from a temporal and country perspective. The results showcased a positive connection between the dependent and independent variables, confirming that the digitization of the economy and the developed human capital will ultimately lead to the increase of population’s welfare. Moreover, the findings are consistent with specific insights for each of the 11 CEECs, showing that digitization and the influence of human capital is differentiated across the latter in terms of their overall effect and amplitude. The research is limited by the timeframe and countries included in the study, and it can be furthered by determining the impact of digitization on the economies of the EU28 countries grouped by level of development, and by using other significant indicators for analysis.

Energy Efficiency Policies in Some of the European Countries

2016 ◽  
pp. 100-131
Author(s):  
Savaş Çevik ◽  
M. Mustafa Erdoğdu ◽  
Fatma Turna
Keyword(s):  
European Union ◽  
Energy Efficiency ◽  
Policy Instruments ◽  
European Countries ◽  
The European Union ◽  
Eu Member States ◽  
Energy Efficiency Policy ◽  
Policy Measures ◽  
Energy Efficiency Policies ◽  
The Impact

This chapter deals with the instruments and policies to achieve energy efficiency in some of the European Union (EU) member states. The main aim of the study is to search for any efficient combination of policy instruments in the EU. The analysis is based on a unique database, derived out of the MURE project, related to energy efficiency policy measures in 28 EU countries and Norway. The study first describes and evaluates the main purposes and instruments of energy efficiency policies. Then, it classifies the measures applied to promote energy efficiency in sample countries by sectors and examines the impact level of different policy packages on energy efficiency.

scholarly journals Competitiveness of Selected South-Eastern European Countries in European Union Wood Flooring Market

2020 ◽  
Vol 71 (3) ◽  
pp. 281-288
Author(s):  
Branko Glavonjić ◽  
Aleksandra Lazarević ◽  
Leon Oblak ◽  
Miljan Kalem ◽  
Predrag Sretenović
Keyword(s):  
European Union ◽  
Growth Index ◽  
European Countries ◽  
Total Production ◽  
Eastern European ◽  
The European Union ◽  
South Eastern ◽  
Wood Flooring ◽  
Eastern European Countries ◽  
The Impact

Selected South-Eastern European countries (SEEC - Albania, Bosnia and Herzegovina, Croatia, Montenegro, North Macedonia, Serbia and Slovenia) represent significant producers and exporters of wood flooring in Europe. In 2018, 9.4 % of Europe’s wood flooring production originated from this region. The region is a net exporter of wood flooring since it exports over 50 % of total production. The most important market for the export of wood flooring is the European Union with a share of over 60 % in total exports. Trends in this market are important for manufacturers and exporters from the region. Therefore, the analysis of the impact of the European Union imports on wood flooring production in the SEEC was conducted by application of econometric modelling. The parameters of the obtained model show that the increase of approximately 0.75 % could be expected in the production of wood flooring in selected South-Eastern European countries for each precentral increase in the European Union imports. In addition to these results, the paper presents the analysis of the competitiveness of wood flooring export from the region measured by the Competitiveness Growth Index (RCA1). The aim of this analysis was to quantify the level of their price and non-price competitiveness in the European Union market. Conducted analyses show that the Competitiveness Growth Index (RCA1) had positive values (higher than one) for most significant countries from the SEEC for most of the observed period.

scholarly journals Social capital and banking system profitability: A survey of European Union countries

2019 ◽  
Vol 8 (1) ◽  
pp. 48-62
Author(s):  
Arash Nayebyazdi
Keyword(s):  
Social Capital ◽  
European Union ◽  
Social Trust ◽  
Banking System ◽  
Capital Adequacy ◽  
European Countries ◽  
The European Union ◽  
Economic Activities ◽  
Main Hypothesis ◽  
The Impact

Over the last years, the concept of social capital as a facilitator of economic activities has been a remarkable issue among economists. In this article, we study the impact of social capital on banking performance focusing on profitability in the European Union for period 2008-2016. Social capital indicators are applied in the model are "trust in others" and "fair behavior of others". We expect more profitable banks in societies with higher levels of social capital. According to the type of data, we apply GMM estimator to do more efficient estimations. We use auxiliary variables such as bank asset, capital adequacy, real interest rate, the cost to income ratio as micro variables, GDP and inflation are employed as macros. Our estimations point at a rejection of the main hypothesis. Opportunistic behavior and less social trust result in more profits for European countries. We justify the results in two ways. First, due to the 2008 financial crisis, trust in all institutions has decreased in European countries. The second reason concerns countries with low levels of social capital. The decrease of trust for the banking system is lower than for other institutions. Therefore, that sector may benefit is such circumstances.

scholarly journals INFLUENCE OF THE RELATIONSHIP BETWEEN THE EUROPEAN UNION AND THE PEOPLE'S REPUBLIC OF CHINA IN THE ASPECT OF THE INTERNATIONAL TRANSPORT CORRIDOR «WESTERN EUROPE-WESTERN CHINA» ON KAZAKHSTAN

2020 ◽  
Vol 66 (3) ◽  
Author(s):  
G.U. Birimkulova ◽  
Keyword(s):  
European Union ◽  
Western Europe ◽  
European Countries ◽  
Western China ◽  
People’S Republic Of China ◽  
The European Union ◽  
People's Republic Of China ◽  
Republic Of China ◽  
International Transport ◽  
The Impact

The article considers the role and significance of the project "Western Europe and Western China" between the countries of the European Union and the people's Republic of China in the development of regions of Kazakhstan. In addition, the author focused on the project, where several years ago Kazakhstan began actively discussing the option of turning from China to Western European countries into one of the most important international transport and transit hubs along the roads. At the same time, reference was made to the ancient history that Chinese goods along the silk road were delivered by caravans to Russia and European countries. Analyzed the impact of the relations between the European Union and China on the Republic of Kazakhstan in the framework of the project "Western Europe and Western China".

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