ENDOSEARCH the First European and North American International Clinical Trial Granted by the European Union Testing a Cluster of Biomarkers for the Diagnosis and Prognosis of Endometriosis

2018 ◽  
Vol 25 (7) ◽  
pp. S14
Author(s):  
A. Fazel ◽  
M. Boukerrou ◽  
J. Bouquet de la Jolinière ◽  
S. Brucker ◽  
M. Ceccaroni ◽  
...  
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
North American ◽  
The European Union ◽  
International Clinical Trial ◽  
Diagnosis And Prognosis

Building Fortress Europe

2019 ◽  
pp. 160-191
Author(s):  
David Scott FitzGerald
Keyword(s):  
European Union ◽  
Remote Control ◽  
North American ◽  
Control Strategies ◽  
Border Control ◽  
The European Union ◽  
The North ◽  
Fortress Europe ◽  
The Individual

The European Union since the 1990s has been engaged in a unique project of reducing mobility controls between members while strengthening the external borders and then shifting control outward. The individual pieces of the remote control strategies themselves are common, with the exception of the Frontex external border control coordinating agency, which does not have parallels in the North American or Australian cases. Europeanization has cross-cutting effects on remote control. The ubiquity of policies rooted in law, regulations, or formal agreements with other states—around readmission, visas, carrier sanctions, safe third countries, and safe countries of origin—is a result of Europeanization. However, Europeanization also includes built-in constraints derived from its supranational courts and institutions.

Regulation of Clinical Trials

2021 ◽  
pp. 195-212
Keyword(s):  
Clinical Trial ◽  
European Union ◽  
Information System ◽  
Clinical Trials ◽  
Well Being ◽  
The European Union ◽  
Approval Process ◽  
Clinical Trials Regulation ◽  
Clinical Trial Information ◽  
The Eu

This chapter discusses the publication of the European Clinical Trials Directive in 2001 and its incorporation into the law of Member States. It explores the intention of the Directive in harmonising the rules for conducting clinical trials within the EU to facilitate the internal market in medicinal products and to protect the rights, safety, and well-being of participants. It also covers the passing of the new Clinical Trials Regulation (CTR) by the EU in 2014, which was prompted by concern that the system for approving clinical trials was overly bureaucratic and that it was hampering multinational trials. The CTR could not come into force until the Clinical Trial Information System (CTIS), which is intended to provide a single coordinated approval process, became fully functional. This happened too late for the CTR to be automatically incorporated into UK law by the European Union (Withdrawal) Act 2018.

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