title: A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union.
authors.forename: Georgios
authors.initials: G
authors.lastname: Amexis
authors.forename: Elmar
authors.initials: E
authors.lastname: Schmitt
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D015195:Drug Design; D005062:European Union; D006801:Humans; D013997:Time Factors