Standard
Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries. / Gluud, Christian; Kubiak, Christine; Whitfield, Kate; Byrne, Jane; Huemer, Karl-Heinz; Thirstrup, Steffen; Libersa, Christian; Barraud, Béatrice; Grählert, Xina; Dreier, Gabriele; Geismann, Sebastian; Kuchinke, Wolfgang; Temesvari, Zsuza; Blasko, Gyorgy; Kardos, Gabriella; O'Brien, Timothy; Cooney, Margaret; Gaynor, Siobhan; Schieppati, Arrigo; de Andres, Fernando; Sanz, Nuria; Kreis, German; Asker-Hagelberg, Charlotte; Johansson, Hanna; Bourne, Sue; Asghar, Adeeba; Husson, Jean-Marc; Demotes-Mainard, Jacques.
In:
Trials, Vol. 13, 2012, p. 27.
Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
Gluud, C, Kubiak, C, Whitfield, K, 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, vol. 13, pp. 27.
https://doi.org/10.1186/1745-6215-13-27APA
Gluud, C., Kubiak, C., Whitfield, K., 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/10.1186/1745-6215-13-27Vancouver
Gluud C, Kubiak C, Whitfield K, Byrne J, Huemer K-H
, Thirstrup S et al.
Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries.
Trials. 2012;13:27.
https://doi.org/10.1186/1745-6215-13-27Author
Gluud, Christian ; Kubiak, Christine ; Whitfield, Kate ; Byrne, Jane ; Huemer, Karl-Heinz ; Thirstrup, Steffen ; Libersa, Christian ; Barraud, Béatrice ; Grählert, Xina ; Dreier, Gabriele ; Geismann, Sebastian ; Kuchinke, Wolfgang ; Temesvari, Zsuza ; Blasko, Gyorgy ; Kardos, Gabriella ; O'Brien, Timothy ; Cooney, Margaret ; Gaynor, Siobhan ; Schieppati, Arrigo ; de Andres, Fernando ; Sanz, Nuria ; Kreis, German ; Asker-Hagelberg, Charlotte ; Johansson, Hanna ; Bourne, Sue ; Asghar, Adeeba ; Husson, Jean-Marc ; Demotes-Mainard, Jacques. / Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries. In: Trials. 2012 ; Vol. 13. pp. 27.
Bibtex
@article{2f63f62c81dc4efcbea71134a80c1baf,
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 Kate Whitfield 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",
year = "2012",
doi = "10.1186/1745-6215-13-27",
language = "English",
volume = "13",
pages = "27",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd.",
}
RIS
TY - JOUR
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
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
VL - 13
SP - 27
JO - Trials
JF - Trials
SN - 1745-6215
ER -
