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

@inproceedings{Gluud2012TypicalIM,
  title={Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries},
  author={Christian N Gluud and Christine Kubiak and Kate Whitfield and J. M. Byrne and Karl-Heinz Huemer and Steffen Thirstrup and Christian Libersa and B{\'e}atrice Barraud and Xina Graehlert and Gabriele Dreier and Sebastian Geismann and Wolfgang Kuchinke and Zsuzsa Temesvari and Gy{\"o}rgy Blask{\'o} and Gabriella Kardos and Timothy O'Brien and Margaret H. Cooney and Siobhan Gaynor and Arrigo Schieppati and Fernando de Andres and Nuria Sanz and Germ{\'a}n Kreis and Charlotte Asker-Hagelberg and Hanna Johansson and Sue Bourne and Adeeba Asghar and Jean-Marc Husson and Jacques Demotes-Mainard},
  booktitle={Trials},
  year={2012}
}
BACKGROUND 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. METHODS We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary… CONTINUE READING
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