An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014

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Iñigo de Miguel Beriain, Timo Minssen, Theodora Chortara, Aliuska Duardo-Sánchez, Oliver Feeney, Heike Felzmann, Emma Fernández de Uzquiano, Elisa Lievevrouw, Luca Marelli, Titti Mattsson, Elisabetta Pulice, Vera Lúcia Raposo, Jürgen Robienski, Simone Penasa, Simone Penasa, Ine Van Hoyweghen, Janne Rothmar Herrmann

This article delivers a comparative analysis of the implementation of the new clinical trials regulation and the characteristics of the ethics committees located in a wide range of EU Member States. It provides information about key variables, such as the legal framework corresponding to the EU Member State where the committees are located, the organization of the committees, their incentives and disposition to supervise clinical trials, etc. The analysis covers several EU Member States, including Belgium, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Spain and Sweden. These have been chosen taking into account several factors, such as their population, geographical location, cultural tradition, as well as the particularities of their current regulation on clinical trials. Together, they form a sample ideally tailored to probe the shape of the regulatory landscape in the EU ahead of the implementation of the new legal framework
Original languageEnglish
JournalEuropean Public Law
ISSN1354-3725
Publication statusAccepted/In press - Jun 2019

ID: 222343551