Browsing by Author "Husson, Jean-Marc"

Now showing items 1-2 of 2

    • Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the european clinical research infrastructures network (ecrin) 

      Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang; Huemer, Karl-Heinz; Thirstrup, Steffen; Whitfield, Kate; Libersa, Christian; Barraud, Béatrice; Grählert, Xina; Dreier, Gabriele; Grychtol, Ruth; Temesvari, Zsuzsa; Blasko, Gyorgy; Kardos, Gabriella; O'Brien, Timothy; Cooney, Margaret; Gaynor, Siobhan; Schieppati, Arrigo; Sanz, Nuria; Hernandez, Raquel; Asker-Hagelberg, Charlotte; Johansson, Hanna; Bourne, Sue; Byrne, Jane; Asghar, Adeeba; Husson, Jean-Marc; Gluud, Christian; Demotes-Mainard, Jacques (Springer Nature, 2009-10-16)
      Background: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception ...

    • 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 (Springer Nature, 2012-03-27)
      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 ...