title: European perspective on risk management and drug safety.
abstract: Risk management is an approach that has been used for many years in areas of business and government such as finance and insurance, but its use in the regulation of medicines has until recently been limited to tools such as the prescription status of a medicine (prescription-only or over-the-counter), the information provided to health-care professionals and patients, and the collection and evaluation of postmarketing safety reports.
authors.affiliation: Medicines and Healthcare Products Regulatory Agency, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Raine
authors.forename: L
authors.initials: L
authors.lastname: Wise
authors.forename: S
authors.initials: S
authors.lastname: Blackburn
authors.forename: H-G
authors.initials: HG
authors.lastname: Eichler
authors.forename: A
authors.initials: A
authors.lastname: Breckenridge
mesh_terms: D017326:Clinical Trials, Phase III as Topic / Q000592:standards / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions; D005060:Europe; D005062:European Union; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards; D012308:Risk Management / Q000379:methods* / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations