Cancer Drug Development and the Evolving Regulatory Framework for Companion Diagnostics in the European Union

2014 ◽  
Vol 20 (6) ◽  
pp. 1458-1468 ◽  
Author(s):  
Francesco Pignatti ◽  
Falk Ehmann ◽  
Robert Hemmings ◽  
Bertil Jonsson ◽  
Micha Nuebling ◽  
...  
Keyword(s):  
European Union ◽  
Drug Development ◽  
Regulatory Framework ◽  
Cancer Drug ◽  
The European Union ◽  
Companion Diagnostics

scholarly journals COMPLIANCE OF CORPORATE GOVERNANCE IN BOSNIA AND HERZEGOVINA WITH EUROPEAN UNION STANDARDS

2018 ◽  
pp. 340-355
Keyword(s):  
European Union ◽  
Corporate Governance ◽  
Bosnia And Herzegovina ◽  
Legal Framework ◽  
Regulatory Framework ◽  
Quality Level ◽  
The European Union ◽  
Governance System ◽  
Governance Systems ◽  
Principles And Standards

Corporate governance provides an answer to the question who controls the corporation and how. It involves a set of relationships between management, shareholders and stakeholders. Corporate governance in Bosnia and Herzegovina is within the legal jurisdiction of entities, and consequently there are two substantially aligned and yet completely distinct corporate governance systems, which separates Bosnia and Herzegovina as a state in the international environment into a specific category in terms of corporate governance. This paper will analyze ownership concentration in order to identify the characteristics of the corporate governance systems, then it will present the principles on which the legal framework for corporate governance in Bosnia and Herzegovina is defined, compare the business transparency standards with the transparency directive in the EU, and measure the quality level of corporate governance in order to define key areas for improvement of corporate governance in Bosnia and Herzegovina. The development and characteristics of the corporate governance systems in Bosnia and Herzegovina will be explored and compared with the regulatory framework and standards of corporate governance in the European Union. Special emphasis is on comparing the transparency principles and standards of corporations in Bosnia and Herzegovina with corporations in the European Union. The aim of the research is to compare the regulatory framework and characteristics of the corporate governance system in corporations in Bosnia and Herzegovina with the standards in the European Union, to identify similarities and differences and to define key areas for improvement of corporate governance in Bosnia and Herzegovina.

Datos abiertos y reutilización en el contexto de la Estrategia europea de datos

Tábula ◽  
2021 ◽  
pp. 201-213
Author(s):  
Julián Valero Torrijos
Keyword(s):  
European Union ◽  
Public Sector ◽  
Open Data ◽  
Regulatory Framework ◽  
Open Government ◽  
The European Union ◽  
Public Sector Information ◽  
Significant Process ◽  
Datos Abiertos

En los últimos años hemos asistido a un importante proceso de modernización tecnológica en España que ha afectado a las Administraciones Públicas. Más allá de las limitaciones en la regulación, en este proceso se percibe la importancia de los datos en general y de los datos abiertos en particular como uno de los ejes principales para reforzar las exigencias y principios del Gobierno Abierto. En esta ponencia se pretende analizar la evolución del marco normativo aplicable en España y ponerlo en relación con las recientes iniciativas que está impulsando la Unión Europea para promocionar la reutilización de la información del sector público y los datos abiertos. In the last few years we have witnessed a significant process of technological modernisation in Spain that has impacted on Public Administrations. Beyond the limitations in the regulation, in this process the importance of data and open data particularly is perceived as one of the main axes to strengthen the requirements and principles of Open Government. This lecture aims to analyse the evolution of the regulatory framework applicable in Spain and to connect it with the recent initiatives being promoted by the European Union to foster the reuse of public sector information and open data.

Critical Review of SME Regulation Optimization in Serbia

2020 ◽  
pp. 1623-1645
Author(s):  
Olgica Milošević
Keyword(s):  
European Union ◽  
Legal System ◽  
Critical Review ◽  
Regulatory Framework ◽  
Theoretical Base ◽  
The European Union ◽  
Legal Requirements ◽  
The Republic ◽  
Legal Forms ◽  
Political Economic

The European Union (EU) and the Republic of Serbia have recognized the importance of SMEs and are developing accordingly the institutional framework of this sector. In the process of EU accession, Serbia has to fulfil political, economic and legal requirements by implementing systemic reforms of its legal system in order to align it with the EU acquis. Some of these requirements have a direct or indirect impact on SME regulations, to which our chapter has been dedicated within a series of our papers on developing the SME regulatory framework. This paper will try to present the importance of innovating legal development of these companies. Furthermore, modern concepts will be introduced together with very important tools of legal forms of SME organization. The intention is to clearly define specific legal goals of SMEs, expressed through targeted legal forms. The modern regulatory framework relating to SMEs should combine the existing solid theoretical base and innovative models from the practice.

scholarly journals Disagreement on cancer drug decisions in Europe

2020 ◽  
Vol 36 (3) ◽  
pp. 232-238
Author(s):  
Laia Maynou ◽  
John Cairns
Keyword(s):  
European Union ◽  
Health Technology ◽  
European Countries ◽  
Primary Data ◽  
Cancer Drug ◽  
The European Union ◽  
Reliability Measures ◽  
Drug Reimbursement ◽  
Two Measures ◽  
Voluntary Cooperation

ObjectivesDespite the efforts of the European Union (EU) to promote voluntary cooperation among Health Technology Assessment (HTA) agencies, different reimbursement decisions for the same drug are made across European countries. The aim of this paper is to compare the agreement of cancer drug reimbursement decisions using inter-rater reliability measures.MethodsThis study is based on primary data on 161 cancer drug reimbursement decisions from nine European countries from 2002 to 2014. To achieve our goal, we use two measures to analyze agreement, in other words, congruency: (i) percentage of agreement and (ii) the κ score.ResultsOne main conclusion can be drawn from the analysis. There is a weak to medium agreement among cancer drug decisions in the European countries analyzed (based on the percentage of agreement and the κ score). England and Scotland show the highest consistency between the two measures, showing a medium agreement. These results are in line with previous literature on the congruency of HTA decisions.ConclusionsThis paper contributes to the HTA literature, by highlighting the extent of weak to medium agreement among cancer decisions in Europe.

scholarly journals Regulatory Frameworks for Aquaponics in the European Union

2019 ◽  
pp. 501-522 ◽  
Author(s):  
Tilman Reinhardt ◽  
Kyra Hoevenaars ◽  
Alyssa Joyce
Keyword(s):  
European Union ◽  
Technological Innovation ◽  
Innovation System ◽  
Regulatory Framework ◽  
The European Union ◽  
Institutional Conditions ◽  
Eu Policy ◽  
Regulatory Frameworks ◽  
Eu Policies

AbstractThis chapter provides an overview of the regulatory framework for aquaponics and the perspectives for European Union (EU) policy. Using Germany as an example, we analyze the specific regulations concerning construction and operation of aquaponic facilities and the commercialization of aquaponic products. We then show how aquaponics fits in with different EU policies and how it might contribute to EU sustainability goals. In the end, we provide some recommendations on how institutional conditions could be improved for aquaponics as an emerging technological innovation system.

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