title: Establishing pan-European clinical trials: regulatory compliance and other practical considerations.
abstract: There are currently many concerns in the pharmaceutical and scientific community working in or around clinical research on the EU Directive 2001/20/EC or Clinical Trials Directive. The Directive introduces regulatory requirements for all phases of study in human subjects, drawing no distinction between commercially funded drug trials and non-commercial/academic research. The Directive makes Good Clinical Practice (GCP) a legal requirement in Europe and all clinical research will be subjected to the same rigorous standards including GCP and Good Manufacturing Practice (GMP) application even at the early clinical phases as well as exhaustive pharmacovigilance and protection of trial subjects. Some of these requirements may be seen as additional burden and a brake to clinical research in Europe. However, the application of the directive should provide a single and highly regulated market of 25 European countries for investigational medicinal products. This article reviews the main aspects and areas of concern of the Directive and provide US sponsor with useful references.
authors.affiliation: Voisin Consulting, Paris, France.
authors.forename: Aurelie
authors.initials: A
authors.lastname: Grienenberger
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards*; D015507:Drugs, Investigational; D028744:Ethics Committees, Research; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D012042:Registries
chemical_list: D015507:Drugs, Investigational