Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Christian Gluud; Christine Kubiak; Kate Emily Whitfield; Jane Byrne; Karl-Heinz Huemer; Steffen Thirstrup; Christian Libersa; Béatrice Barraud; Xina Grählert; Gabriele Dreier; Sebastian Geismann; Wolfgang Kuchinke; Zsuza Temesvari; Gyorgy Blasko; Gabriella Kardos; Timothy O'Brien; Margaret Cooney; Siobhan Gaynor; Arrigo Schieppati; Fernando de Andres; Nuria Sanz; German Kreis; Charlotte Asker-Hagelberg; Hanna Johansson; Sue Bourne; Adeeba Asghar; Jean-Marc Husson; Jacques Demotes-Mainard

doi:10.1186/1745-6215-13-27

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Christian Gluud, Christine Kubiak, Kate Emily Whitfield, Jane Byrne, Karl-Heinz Huemer, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Zsuza Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Fernando de AndresNuria Sanz, German Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Sue Bourne, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes-Mainard

Copenhagen Trial Unit Rigshospitalet

7 Citationer (Scopus)

Abstract

In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.

Originalsprog	Engelsk
Tidsskrift	Trials
Vol/bind	13
Sider (fra-til)	27
ISSN	1745-6215
DOI	https://doi.org/10.1186/1745-6215-13-27
Status	Udgivet - 2012

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10.1186/1745-6215-13-27

Citationsformater

Gluud, C., Kubiak, C., Whitfield, K. E., Byrne, J., Huemer, K.-H., Thirstrup, S., Libersa, C., Barraud, B., Grählert, X., Dreier, G., Geismann, S., Kuchinke, W., Temesvari, Z., Blasko, G., Kardos, G., O'Brien, T., Cooney, M., Gaynor, S., Schieppati, A., ... Demotes-Mainard, J. (2012). Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries. Trials, 13, 27. https://doi.org/10.1186/1745-6215-13-27

Gluud, C, Kubiak, C, Whitfield, KE, Byrne, J, Huemer, K-H, Thirstrup, S, Libersa, C, Barraud, B, Grählert, X, Dreier, G, Geismann, S, Kuchinke, W, Temesvari, Z, Blasko, G, Kardos, G, O'Brien, T, Cooney, M, Gaynor, S, Schieppati, A, de Andres, F, Sanz, N, Kreis, G, Asker-Hagelberg, C, Johansson, H, Bourne, S, Asghar, A, Husson, J-M & Demotes-Mainard, J 2012, 'Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries', Trials, bind 13, s. 27. https://doi.org/10.1186/1745-6215-13-27

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title = "Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries",

abstract = "In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.",

keywords = "Biomedical Research, Consumer Product Safety, Device Approval, Drug Approval, Drugs, Investigational, Europe, Government Regulation, Guideline Adherence, Guidelines as Topic, Health Policy, Humans, International Cooperation, Questionnaires",

author = "Christian Gluud and Christine Kubiak and Whitfield, {Kate Emily} and Jane Byrne and Karl-Heinz Huemer and Steffen Thirstrup and Christian Libersa and B{\'e}atrice Barraud and Xina Gr{\"a}hlert and Gabriele Dreier and Sebastian Geismann and Wolfgang Kuchinke and Zsuza Temesvari and Gyorgy Blasko and Gabriella Kardos and Timothy O'Brien and Margaret Cooney and Siobhan Gaynor and Arrigo Schieppati and {de Andres}, Fernando and Nuria Sanz and German Kreis and Charlotte Asker-Hagelberg and Hanna Johansson and Sue Bourne and Adeeba Asghar and Jean-Marc Husson and Jacques Demotes-Mainard",

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doi = "10.1186/1745-6215-13-27",

language = "English",

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T1 - Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

AU - Gluud, Christian

AU - Kubiak, Christine

AU - Whitfield, Kate Emily

AU - Byrne, Jane

AU - Huemer, Karl-Heinz

AU - Thirstrup, Steffen

AU - Libersa, Christian

AU - Barraud, Béatrice

AU - Grählert, Xina

AU - Dreier, Gabriele

AU - Geismann, Sebastian

AU - Kuchinke, Wolfgang

AU - Temesvari, Zsuza

AU - Blasko, Gyorgy

AU - Kardos, Gabriella

AU - O'Brien, Timothy

AU - Cooney, Margaret

AU - Gaynor, Siobhan

AU - Schieppati, Arrigo

AU - de Andres, Fernando

AU - Sanz, Nuria

AU - Kreis, German

AU - Asker-Hagelberg, Charlotte

AU - Johansson, Hanna

AU - Bourne, Sue

AU - Asghar, Adeeba

AU - Husson, Jean-Marc

AU - Demotes-Mainard, Jacques

PY - 2012

Y1 - 2012

N2 - In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.

AB - In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.

KW - Biomedical Research

KW - Consumer Product Safety

KW - Device Approval

KW - Drug Approval

KW - Drugs, Investigational

KW - Europe

KW - Government Regulation

KW - Guideline Adherence

KW - Guidelines as Topic

KW - Health Policy

KW - Humans

KW - International Cooperation

KW - Questionnaires

U2 - 10.1186/1745-6215-13-27

DO - 10.1186/1745-6215-13-27

M3 - Journal article

C2 - 22452964

SN - 1745-6215

VL - 13

SP - 27

JO - Trials

JF - Trials

ER -

Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Abstract

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