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

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An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014. / de Miguel Beriain, Iñigo ; Minssen, Timo; Chortara, Theodora ; Duardo-Sánchez, Aliuska ; Feeney, Oliver ; Felzmann, Heike ; Fernández de Uzquiano, Emma ; Lievevrouw, Elisa ; Marelli, Luca ; Mattsson, Titti ; Pulice, Elisabetta ; Raposo, Vera Lúcia ; Robienski, Jürgen ; Penasa, Simone ; Penasa, Simone ; Van Hoyweghen, Ine ; Herrmann, Janne Rothmar.

In: European Public Law, Vol. 26, No. 2, 18.06.2020, p. 307-330.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

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 2020, 'An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014', European Public Law, vol. 26, no. 2, pp. 307-330.

APA

de Miguel Beriain, I., Minssen, T., Chortara, T., Duardo-Sánchez, A., Feeney, O., Felzmann, H., ... Herrmann, J. R. (2020). An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014. European Public Law, 26(2), 307-330.

Vancouver

de Miguel Beriain I, Minssen T, Chortara T, Duardo-Sánchez A, Feeney O, Felzmann H et al. An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014. European Public Law. 2020 Jun 18;26(2):307-330.

Author

de Miguel Beriain, Iñigo ; Minssen, Timo ; Chortara, Theodora ; Duardo-Sánchez, Aliuska ; Feeney, Oliver ; Felzmann, Heike ; Fernández de Uzquiano, Emma ; Lievevrouw, Elisa ; Marelli, Luca ; Mattsson, Titti ; Pulice, Elisabetta ; Raposo, Vera Lúcia ; Robienski, Jürgen ; Penasa, Simone ; Penasa, Simone ; Van Hoyweghen, Ine ; Herrmann, Janne Rothmar. / An EU comparative analysis of the regulation of clinical trials supervisory bodies in the aftermath of Regulation 536/2014. In: European Public Law. 2020 ; Vol. 26, No. 2. pp. 307-330.

Bibtex

@article{c09ff605b0d7421784bd77968f64a734,
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 = "2020",
month = "6",
day = "18",
language = "English",
volume = "26",
pages = "307--330",
journal = "European Public Law",
issn = "1354-3725",
publisher = "Kluwer Law International",
number = "2",

}

RIS

TY - JOUR

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 - Penasa, Simone

AU - Van Hoyweghen, Ine

AU - Herrmann, Janne Rothmar

PY - 2020/6/18

Y1 - 2020/6/18

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

UR - https://kluwerlawonline.com/journalarticle/European+Public+Law/26.2/EURO2020046

M3 - Journal article

VL - 26

SP - 307

EP - 330

JO - European Public Law

JF - European Public Law

SN - 1354-3725

IS - 2

ER -

ID: 222343551