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

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

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

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

Abstract

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 language	English
Journal	European Public Law
ISSN	1354-3725
Publication status	Accepted/In press - Jun 2019

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de Miguel Beriain, I., Minssen, T., Chortara, T., Duardo-Sánchez, A., Feeney, O., Felzmann, H., Fernández de Uzquiano, E., Lievevrouw, E., Marelli, L., Mattsson, T., Pulice, E., Raposo, V. L., Robienski, J., Penasa, S., Penasa, S., Van Hoyweghen, I., & Herrmann, J. R. (Accepted/In press). An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014. European Public Law.

de Miguel Beriain, I, Minssen, T, Chortara, T, Duardo-Sánchez, A, Feeney, O, Felzmann, H, Fernández de Uzquiano, E, Lievevrouw, E, Marelli, L, Mattsson, T, Pulice, E, Raposo, VL, Robienski, J, Penasa, S, Penasa, S, Van Hoyweghen, I & Herrmann, JR 2019, 'An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014', European Public Law.

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

abstract = "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",

author = "{de Miguel Beriain}, I{\~n}igo and Timo Minssen and Theodora Chortara and Aliuska Duardo-S{\'a}nchez and Oliver Feeney and Heike Felzmann and {Fern{\'a}ndez de Uzquiano}, Emma and Elisa Lievevrouw and Luca Marelli and Titti Mattsson and Elisabetta Pulice and Raposo, {Vera L{\'u}cia} and J{\"u}rgen Robienski and Simone Penasa and Simone Penasa and {Van Hoyweghen}, Ine and Herrmann, {Janne Rothmar}",

year = "2019",

month = jun,

language = "English",

journal = "European Public Law",

issn = "1354-3725",

publisher = "Kluwer Law International",

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T1 - An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014

AU - de Miguel Beriain, Iñigo

AU - Minssen, Timo

AU - Chortara, Theodora

AU - Duardo-Sánchez, Aliuska

AU - Feeney, Oliver

AU - Felzmann, Heike

AU - Fernández de Uzquiano, Emma

AU - Lievevrouw, Elisa

AU - Marelli, Luca

AU - Mattsson, Titti

AU - Pulice, Elisabetta

AU - Raposo, Vera Lúcia

AU - Robienski, Jürgen

AU - Penasa, Simone

AU - Van Hoyweghen, Ine

AU - Herrmann, Janne Rothmar

PY - 2019/6

Y1 - 2019/6

N2 - 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

AB - 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

M3 - Journal article

SN - 1354-3725

JO - European Public Law

JF - European Public Law

ER -

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

Abstract

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