title: Risk management : a European regulatory perspective.
abstract: Risk management for European regulators means the detection and assessment of risks, the development and selection of measures to reduce risk, and monitoring of the effectiveness of risk control; all aspects of pharmacovigilance intended to minimise risk to European Union citizens associated with use of medicinal substances. This incorporates earlier and better planning of pharmacovigilance through formal product risk-management plans, better use of information tools to protect public health and routine audit of effectiveness of regulatory action.
authors.affiliation: Pharmacoepidemiology Research Team, The Medicines and Healthcare products Regulatory Agency, London, United Kingdom.
authors.forename: Jane N S
authors.initials: JN
authors.lastname: Moseley
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D005062:European Union / Q000458:organization & administration*; D006801:Humans; D011634:Public Health; D012042:Registries; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000379:methods