title: New EU clinical trials regulation.
authors.affiliation: Erasmus University Medical Centre, Department of Medical Ethics and Philosophy of Medicine, 3000 CA Rotterdam, Netherlands a.e.westra@lumc.nl.
authors.forename: Anna E
authors.initials: AE
authors.lastname: Westra
authors.affiliation: Erasmus University Medical Centre, Department of Medical Ethics and Philosophy of Medicine, 3000 CA Rotterdam, Netherlands.
authors.forename: Wendy
authors.initials: W
authors.lastname: Bos
authors.affiliation: Centre for Human Drug Research, Zernikedreef 10, 2333 CL, Leiden, Netherlands.
authors.forename: Adam F
authors.initials: AF
authors.lastname: Cohen
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research; D005062:European Union; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans