title: The new EU legislation on pharmacovigilance and changing models for drug development.
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Callréus
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing; D011634:Public Health / Q000331:legislation & jurisprudence*; D012107:Research Design