scholarly journals Future veterinary drug approval in the European Union: a paradigm shift causing changes, challenges and opportunities

2021 ◽  
Author(s):  
Thomas Heberer
Keyword(s):  
European Union ◽  
Paradigm Shift ◽  
Drug Approval ◽  
Veterinary Drug ◽  
The European Union ◽  
Challenges And Opportunities

scholarly journals The new European Union space policy in order to maintain Europe’s position among space leaders

2019 ◽  
pp. 20-31
Author(s):  
Piotr Kolczynski
Keyword(s):  
European Union ◽  
Outer Space ◽  
Public Institutions ◽  
Space Policy ◽  
The European Union ◽  
Private Companies ◽  
The Public ◽  
Eu Member States ◽  
Challenges And Opportunities ◽  
The Right

This paper analyzes the current EU space strategy and confronts it with existing global challenges in the space sector. The ultimate aim of this research is to recommend a well-adjusted space policy for the European Commission to ensure effective and sustainable exploration and use of outer space for the benefit of all EU member-states. In order to draft the most efficient space policy, the uniqueness of Europe’s space sector is studied. This paper argues that the EU space policy has to focus on guaranteeing European autonomy in access and use of outer space. The author extensively analyzes the challenges and opportunities related to dynamic development of private space sector’s activities. Emphasis is made on the significance of symbiotic cooperation between the public institutions and private companies regarding mutual benefits. The paper concludes that it is the right time for the European Union to build a bold and prospective space policy.

scholarly journals Challenges and Opportunities to Regional Renewal in the European Union

2020 ◽  
Vol 44 (1) ◽  
pp. 142-169
Author(s):  
Nicola Pontarollo ◽  
Carolina Serpieri
Keyword(s):  
European Union ◽  
Economic Downturn ◽  
Regional Economies ◽  
The European Union ◽  
European Regions ◽  
Economic Resilience ◽  
New Member States ◽  
European Union Countries ◽  
Challenges And Opportunities ◽  
Bounce Back

The strength of the 2008 financial and economic crisis and the resulting degree of resilience were heterogeneous among and within the European Union countries. Challenges and opportunities driven by regional-specific differences determined the ability to overshoot the precrisis levels of growth. Focusing upon Nomenclature of Territorial Units for Statistics 2 (NUTS 2) European regions, we explore a novel conceptual framework related to regional economic resilience, namely the renewal capacity. Precisely, we concentrate on the capacity of regional economies to “renew” their growth paths in the labor market in the aftermath of the recent global crisis. We find some well-identified spatial patterns of regional employment renewal and we identify a set of territorial assets that allow regions to bounce back faster and more comprehensively than others to the economic downturn. Furthermore, there are significant differences between the drivers of the regional renewal of Old and New Member States. Our findings suggest potential policy directions at all levels for enhancing regional resilience.

Pharmaceutical Regulation in the European Union

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
European Union ◽  
Drug Approval ◽  
Good Clinical Practice ◽  
The United States ◽  
Good Manufacturing Practice ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
Regulatory Regime ◽  
The European Union ◽  
Regulatory Pathways

The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.

scholarly journals Changing hepatitis A epidemiology in the European Union: new challenges and opportunities

2015 ◽  
Vol 20 (16) ◽  
Author(s):  
C M Gossner ◽  
E Severi ◽  
N Danielsson ◽  
Y Hutin ◽  
D Coulombier
Keyword(s):  
European Union ◽  
Hepatitis A ◽  
The European Union ◽  
Binary File ◽  
Challenges And Opportunities ◽  
New Challenges

Binary file ES_Abstracts_Final_ECDC.txt matches

Pringle: A Paradigm Shift in the European Union's Monetary Constitution

2013 ◽  
Vol 14 (1) ◽  
pp. 141-168 ◽  
Author(s):  
Pieter-Augustijn Van Malleghem
Keyword(s):  
European Union ◽  
Supreme Court ◽  
Paradigm Shift ◽  
Eu Law ◽  
The European Union ◽  
Member States ◽  
Council Decision ◽  
Monetary Constitution ◽  
European Stability Mechanism ◽  
The Stability

The reference from the Irish Supreme Court seeking a preliminary ruling in the Pringle case concerns the compatibility of the Treaty establishing the European Stability Mechanism (hereinafter ESM Treaty or ESMT) with European Union (EU) law. The Irish Supreme Court was concerned with the legal significance of Council Decision 2011/199, which amended the Treaty on the Functioning of the European Union (TFEU) by inserting a third paragraph in Art 136 TFEU. The new Art 136(3) provides that the Member States whose currency is the euro, may establish a mechanism such as the European Stability Mechanism (ESM) so long as that mechanism is only activated when indispensable to safeguarding the stability of the euro area as a whole, and only if the financial assistance is made subject to strict conditionality. But, because Decision 2011/199 has not yet been ratified by all Member States, the TFEU has not yet been amended. The ESMT nevertheless entered into force at the end of September 2012, and the ESMT commenced its operations in December 2012.

Post-Brexit Global Trade Relations: The Death of TTIP?

2016 ◽  
Vol 17 (S1) ◽  
pp. 39-44
Author(s):  
Amanda Lyons-Archambault
Keyword(s):  
European Union ◽  
Bilateral Trade ◽  
Market Access ◽  
The United States ◽  
Global Trade ◽  
The European Union ◽  
Trade Relations ◽  
Economic Output ◽  
Transatlantic Trade ◽  
Challenges And Opportunities

Prior to Britain's popular referendum on whether to remain a member of the European Union, parts of the public in Britain and other European states had already expressed a great range of emotions concerning on-going negotations between the European Union and the United States regarding the bi-lateral Transatlantic Trade and Investment Partnership, more commonly referred to as “TTIP.” In February 2013, the European Commission optimistically projected that TTIP “would be the biggest bilateral trade-deal ever negotiated,” with the potential to “add 0.5% to the EU's annual economic output.” Most notably, TTIP seeks to streamline administrative rules and technical product standards in order to remove trade barriers, and aims to “achieve ambitious outcomes” across three broader areas—(a) market access, (b) regulatory issues and non-tariff barriers, and (c) rules, principles, and new modes of cooperation to address shared global trade challenges and opportunities.

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