scholarly journals Extension of Indication for Authorised Oncology Products in the European Union: A Joint Effort of Multiple Stakeholders

2021 ◽  
Vol 8 ◽  
Author(s):  
Jorn Mulder ◽  
Robin Verjans ◽  
Ciska Verbaanderd ◽  
Elias Pean ◽  
Just Weemers ◽  
...  
Keyword(s):  
European Union ◽  
Medicinal Product ◽  
Marketing Authorisation ◽  
Therapeutic Indication ◽  
Regulatory Approval ◽  
The European Union ◽  
Regulatory Requirements ◽  
Marketing Authorisation Holder ◽  
Investigator Initiated Trials

After marketing authorisation, the development of a medicinal product often continues with studies investigating new therapeutic indications. Positive results can potentially lead to changes to the terms of the marketing authorisation, such as an extension of therapeutic indication(s). These studies can be initiated and sponsored by the marketing authorisation holder (MAH) or by others. When results from an investigator-initiated trial suggest that an authorised medicinal product is safe and effective for a new therapeutic indication, physicians may want to treat their patients with this medicinal product. In such a situation, it is desirable to extend the therapeutic indication(s) via the regulatory approval process, as this can facilitate patient access within the European Union. There may however be challenges when the MAH did not conduct the study and might not have access to the data. In this perspective, we focus on the possibilities to extend the therapeutic indication(s) of an already authorised medicinal product based on results from investigator-initiated trials. We address: (1) the advantages of an extension of indication; (2) the regulatory requirements for a variation application; (3) investigator-initiated trials as a basis for regulatory approval; (4) the role of the MAH in extending the indication. With this article, we want to emphasize the importance of a collaborative approach and dialogue between stakeholders with the aim to facilitate access to effective medicinal products.

STUDY OF MOVEMENTS MOBILITY-IMPAIRED POPULATION GROUPS IN PEDESTRIAN ZONES OF THE STREET-ROAD NETWORK (in the example of city of Kiev)

2017 ◽  
Author(s):  
Oleksandra Cherednichenko ◽  
Keyword(s):  
European Union ◽  
Comparative Analysis ◽  
Road Network ◽  
Actual State ◽  
The European Union ◽  
Regulatory Requirements ◽  
Population Groups ◽  
The Road ◽  
Mobility Impaired

The results of the study of the main elements of unobstructed space are presented and the compliance of the actual state with the regulatory requirements of measures to ensure a safe, comfortable, accessible and informative pedestrian zone of the road network is analyzed. A comparative analysis of the main regulatory requirements for access ramps on the legislation of Ukraine and the European Union is carried out.

TERRITORIAL COHESION POLICY IN THE CONTEXT OF EU REGIONAL SECURITY

2019 ◽  
Vol 18 (Vol 18, No 4 (2019)) ◽  
pp. 439-453
Author(s):  
Ihor LISHCHYNSKYY
Keyword(s):  
European Union ◽  
Sustainable Development ◽  
Regional Security ◽  
The European Union ◽  
Cohesion Policy ◽  
Cross Border ◽  
Territorial Cohesion ◽  
Interregional Cooperation ◽  
The Eu

The article is devoted to the study of the implementation of territorial cohesion policy in the European Union in order to achieve a secure regional coexistence. In particular, the regulatory and institutional origins of territorial cohesion policy in the EU are considered. The evolution of ontological models of cohesion policy has been outlined. Specifically, the emphasis is placed on the key objective of political geography – effectively combining the need for "territorialization" and the growing importance of networking. The role of urbanization processes in the context of cohesion policy is highlighted. Cross-border dimensions of cohesion policy in the context of interregional cooperation are explored. Particular emphasis is placed on the features of integrated sustainable development strategies.

The promotion of security sector reform strategies: Comparing the roles of the European Union and Canada

2007 ◽  
Author(s):  
Antoine Vandemoorteele
Keyword(s):  
European Union ◽  
International Organizations ◽  
Policy Framework ◽  
The European Union ◽  
Security Sector Reform ◽  
Security Sector ◽  
Post Conflict ◽  
The Eu ◽  
Common Policy

This article analyzes the role of the European Union (EU) and Canada in the promotion of Security Sector Reforms (SSR) activities in two regional organizations, the Organization for Security and Cooperation in Europe (OSCE) and the North Atlantic Treaty Organization (NATO). The concept of SSR seeks to address the effective governance of security in post-conflict environment by transforming the security institutions within a country in order for them to have more efficient, legitimate and democratic role in implementing security. Recent debates within the EU have led to the adoption of an SSR concept from the Council and a new strategy from the European Commission on the SSR activities. Within the framework of the ESDP, the EU has positioned itself as a leading actor, in this domain, including in its crisis management operations. On the other hand, Canada, through its whole-of government and human security programs has also been an important actor in the promotion of SSR activities. Yet, even though several international organizations (including the United Nations, the OSCE and NATO) are effectively doing SSR activities on the ground, there does not exist a common framework within any of these organizations despite the role of the EU and Canada. As such, it is surprising to found no global common policy for SSR while this approach is precisely holistic in its foundations. Taking these elements into consideration, this paper analyzes two specific aspects : a) the absence of a common policy framework within international organizations and b) the major differences between the approaches of the OSCE and NATO in the domain of SSR and the implications for the EU and Canada’ roles.   Full extt available at: https://doi.org/10.22215/rera.v3i2.186

THE ROLE OF NON-GOVERNMENTAL ORGANIZATIONS (NGOs) AS INTERMEDIARIES OF THE EUROPEAN UNION DECISION TO ADOPT INTERNATIONAL ACCOUNTING STANDARDS: 1973–2002

2016 ◽  
Vol 43 (2) ◽  
pp. 59-127 ◽  
Author(s):  
Devrimi Kaya ◽  
Robert J. Kirsch ◽  
Klaus Henselmann
Keyword(s):  
European Union ◽  
Accounting Standards ◽  
International Accounting ◽  
International Accounting Standards ◽  
The European Union ◽  
Governmental Organizations ◽  
Non Governmental Organizations ◽  
History Of ◽  
The Many

This paper analyzes the role of non-governmental organizations (NGOs) as intermediaries in encouraging the European Union (EU) to adopt International Accounting Standards (IAS). Our analysis begins with the 1973 founding of the International Accounting Standards Committee (IASC), and ends with 2002 when the binding EU regulation was approved. We document the many pathways of interaction between European supranational, governmental bodies and the IASC/IASB, as well as important regional NGOs, such as the Union Européenne des Experts Comptables, Économiques et Financiers (UEC), the Groupe d'Etudes des Experts Comptables de la Communauté Économique Européenne (Groupe d'Etudes), and their successor, the Fédération des Experts Comptables Européens (FEE). This study investigates, through personal interviews of key individuals involved in making the history of the organizations studied, and an extensive set of primary sources, how NGOs filled key roles in the process of harmonization of international accounting standards.

The Role of National Constitutional Courts in European Democracy

2017 ◽  
Author(s):  
Dieter Grimm
Keyword(s):  
European Union ◽  
Economic Liberalization ◽  
Democratic Legitimacy ◽  
European Law ◽  
The European Union ◽  
Constitutional Courts ◽  
European Court ◽  
European Democracy ◽  
And Function

This chapter examines the role of national constitutional courts in European democracy. It first provides an overview of national constitutional courts in Europe, focusing on the requirements that they impose on national institutions and the consequences of those requirements at the treaty level—i.e., transferring national powers to the European Union and regulating how these powers are exercised; at the level of the EU’s exercise of these powers; and at the level of implementing European law within national legal systems. The chapter also discusses how the European Court of Justice’s jurisprudence enabled the European treaties to function as a constitution; the non-political mechanism of EU decisions and how it promotes economic liberalization; and how the design and function of European primary law undermine democracy. The chapter suggests that the democratic legitimacy imparted to the EU’s decisions by its citizens can only develop within the framework of the European Parliament’s powers.

scholarly journals Jewish Perceptions of Antisemitism in the European Union, 2018: A New Structural Look

2020 ◽  
Vol 40 (2) ◽  
Author(s):  
Sergio DellaPergola
Keyword(s):  
European Union ◽  
Research Literature ◽  
The European Union ◽  
Research Issues ◽  
Similarity Structure ◽  
Methodological Problems ◽  
Prejudice And Discrimination ◽  
Anti Jewish ◽  
The Eu

AbstractThis paper aims at providing a new systemic contribution to research about perceptions of antisemitism/Judeophobia by contemporary Jews in 12 European Union countries. The perspective – the viewpoint of the offended side – has been less prominent relatively in research literature on antisemitism. The data analysis demonstrates the potential power of Similarity Structure Analysis (SSA) as a better theoretical and empirical tool to describe and conceptualize the contents of chosen research issues. After a brief review of some methodological problems in the study of antisemitism, this paper will re-elaborate data first published in the report of the 2018 FRA study Experiences and Perceptions of Antisemitism – Second survey on Discrimination and Hate Crimes against Jews in the EU (FRA 2018a). Topics include the perceived importance of antisemitism as a societal issue, the contents of anti-Jewish prejudice and discrimination, channels of transmission, perpetrators of offenses, regional differences within Europe, and the role of antisemitism perceptions as a component of Jewish identification. Special attention is paid to the distinction between cognitive and experiential perceptions of antisemitism, and to the typology of practical, populist, political, and narrative antisemitism.

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