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

Research output: Contribution to journalJournal articleResearchpeer-review

  • Christian Gluud
  • Christine Kubiak
  • Kate Whitfield
  • Jane Byrne
  • Karl-Heinz Huemer
  • 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
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.
Original languageEnglish
JournalTrials
Volume13
Pages (from-to)27
ISSN1745-6215
DOIs
Publication statusPublished - 2012

    Research areas

  • 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

ID: 48998962