title: Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee.
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4 HB, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Arlett
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4 HB, UK.
authors.forename: Geraldine
authors.initials: G
authors.lastname: Portier
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4 HB, UK.
authors.forename: Roberto
authors.initials: R
authors.lastname: de Lisa
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4 HB, UK.
authors.forename: Kevin
authors.initials: K
authors.lastname: Blake
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4 HB, UK.
authors.forename: Noel
authors.initials: N
authors.lastname: Wathion
authors.affiliation: Federal Agency for Medicines and Health Products, Victor Horta Place, 40/40, 1060 Brussels, Belgium.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Dogne
authors.affiliation: Irish Medicines Board, Earlsfort Terrace Dublin 2, Ireland.
authors.forename: Almath
authors.initials: A
authors.lastname: Spooner
authors.affiliation: Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, London SW1W 9SZ, UK.
authors.forename: June
authors.initials: J
authors.lastname: Raine
authors.affiliation: European Medicines Agency, 7 Westferry Circus, Canary Wharf, London E14 4 HB, UK.
authors.forename: Guido
authors.initials: G
authors.lastname: Rasi
mesh_terms: D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence* / Q000379:methods; D005062:European Union; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D018570:Risk Assessment