Key pharmacovigilance stakeholders' experiences of direct patient reporting of adverse drug reactions and their prospects of future development in the European Union

Public Health ◽  
2018 ◽  
Vol 155 ◽  
pp. 119-128 ◽  
Author(s):  
P. Inácio ◽  
A. Cavaco ◽  
E. Allan ◽  
M. Airaksinen
2020 ◽  
Vol 29 (11) ◽  
pp. 1523-1526
Author(s):  
Miguel Á. Cano‐Sandoval ◽  
Gabriela C. López‐Armas ◽  
Yocanxóchitl Perfecto‐Avalos ◽  
Alan O. Vázquez‐Alvarez ◽  
Lorena M. Brennan‐Bourdon

Drug Safety ◽  
2013 ◽  
Vol 36 (4) ◽  
pp. 267-276 ◽  
Author(s):  
Roberto Leone ◽  
Ugo Moretti ◽  
Paola D’Incau ◽  
Anita Conforti ◽  
Lara Magro ◽  
...  

Author(s):  
Carla Pires ◽  
Dinah Duarte

In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.


2020 ◽  
Vol 28 (2) ◽  
pp. 146-154
Author(s):  
Ines Kersan-Škabić

The heterogeneity of economic performances in the EU member states is one of the main reasons for the existence of a “core-periphery” relationship. The goal of this research is to examine various economic indicators to reveal possible divisions between the EU members. This issue emphasized the contribution of rich “core” countries to the imbalances in poorer “peripheral” EU members. By applying cluster methodology and considering the most recent data, two groups of countries were identified, the first comprising 11 countries that form the “centre” or the “core”, and the rest of the EU forming the “periphery”. Considering differences between these countries is necessary and justified for discussions about the future development of the EU that will involve differences between member states.


2014 ◽  
Vol 22 (50) ◽  
pp. 33-48 ◽  
Author(s):  
Kai Lehmann

It is common today, even in the European media, to treat the current crisis of the European Union almost exclusively as an economic crisis. The present article pretends to show that such a focus is not only wrong but is indeed dangerous for the future development of the European Union as a whole. The article will argue that the present economic crisis simply aggravated – and a lot – a crisis of legitimacy through which the European Union has been passing for some time. Showing that the anti-European tendencies which are spreading throughout the countries of the continent threaten the very future of the European project, the article will make suggestion on reforms for the future development of the EU, alerting to the necessity to finally elaborate once again a coherent argument for the continuation of the European integration process which puts the European population at the heart of the political process instead of just austerity.


2003 ◽  
Vol 7 (3) ◽  
pp. 219-224 ◽  
Author(s):  
Narumol Jarernsiripornkul ◽  
Janet Krska ◽  
R. Michael E. Richards ◽  
Phillip A.G. Capps

2016 ◽  
Vol 83 (4) ◽  
pp. 875-883 ◽  
Author(s):  
Rania Al Dweik ◽  
Dawn Stacey ◽  
Dafna Kohen ◽  
Sanni Yaya

2019 ◽  
Vol 5 (4) ◽  
pp. 221
Author(s):  
Andrii Falkovskyi ◽  
Olga Dzhezhik

In the scientific discourse of the XXI century, the concept of modern Europe is being reformed under the influence of reforming the activities of the European Union. Scientific publications and research are conducted based on a study of the policies of the European Union countries, EU institutions and structural elements, and the problems that arise in the process of activity and development. The concept of modern Europe is a general term that embraces European values, the European standard of living, European policy, and European priorities, giving the concept of European studies a stable association with the European Union. In this context, the main causes and consequences for the scientific discourse, political practice, and future development of European countries must be considered. Neoinstitutionalists have attempted to analyse institutions based on atomistic methodology. Institutional transformations, processes of intra-European integration and enlargement of the EU, discussions on membership and exit from the EU raise issues of identity and development of governance in Europe. Europeanisation can be seen as a discourse, governance, and institutionalisation. The first interpretation emphasizes that modern Europe is a discourse, not only ideological but also administrative. In this sense, Europeanisation can be a means of expression of institutional globalization through domestic policy. In the article, the hypothesis is put forward and proved that the interpretation of the concept of modern Europe directly correlates with the future development of the European Union and its members. The dissemination of exclusive practices will help to spread the ideas of radical “Eurosceptics”, which could lead to the collapse of the European Union. The inclusive aspect of the concept of Europe is represented by the ideas of “Europeists” who, based on the common history, culture, mentality of the peoples of Europe, substantiate the positive influence on the state development of integration, non-state cooperation, and extrapolation of EU norms and principles into the new territories of Europe. There are three main reasons for shaping the concept of Europe as the boundaries of EU policy: The consolidation of political positions of the European Union and its growing role as an actor in world politics; Essence of the EU enlargement concepts; Features of development within the European community. The modern concept of Europe is considered in the context of a modern multi-level governance model. Therefore, Europeanisation is the interaction of different layers of interests, including structures of regional, multi-level governance, legitimacy of domestic and foreign policy. The impact of the multi-level governance system on the functioning of public administration systems in the Member States and neighbouring countries is considered. Four approaches are identified based on the analysis of relationships between different levels of governance. The necessity of formulating new theoretical paradigms defining the relations between the Member States and the technocratic institutions of the EU, as well as between the Europeanised system of national agencies and the ministries overseeing their activities, has been proved.


2012 ◽  
Vol 51 (02) ◽  
pp. 35-46 ◽  
Author(s):  
D. Hellwig ◽  
L. S. Freudenberg ◽  
F. M. Mottaghy ◽  
C. Franzius ◽  
T. Krause ◽  
...  

SummaryThe technical developments that have taken place in the preceding years (PET, hybrid imaging) have changed nuclear medicine. The future cooperation with radiologists will be challenging as well as positioning nuclear medicine in an European context. It can also be expected that education in nuclear medicine will undergo a harmonization process in the states of the European Union.In this paper, we describe how nuclear medicine education is organized in several European countries. We aim to stimulate constructive discussions on the future development of the specialization in nuclear medicine in Germany.


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