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Health / Medicine / Drug safety / Pharmaceutical industry / Pharmaceuticals policy / Pharmacovigilance / EudraVigilance / European Medicines Agency / Adverse event / Clinical research / Pharmaceutical sciences / Pharmacology


22 June 2012 EMAGuideline on good pharmacovigilance practices (GVP) Module IX – Signal management
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Document Date: 2013-07-21 06:33:00


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City

Geneva / /

Company

Heads of Medicines Agencies / Member States / Draft / VIII Practical Aspects / The European Medicines Agency / Member 20 June / /

Event

Product Issues / Business Partnership / /

IndustryTerm

teratology information services / concerned active substance/medicinal products / spontaneous reporting systems / statistical tools / healthcare professionals / active surveillance systems / active substance/medicinal product / signal management / manufacturing defect / regulatory network / medicinal product / suspected medicinal product / digital media / active substances/medicinal products / potential high media / medicinal products / concerned active substance/medicinal product / Record management / /

MedicalCondition

torsades de pointes / disease / complex disease / optic neuritis / toxic epidermal necrolysis / target disease / multiple sclerosis / clinical syndrome / e.g. dehydration / acute renal failure / /

MedicalTreatment

liver transplant / /

Organization

Council for International Organisations of Medical Sciences Working / e.g. / European Medicines Agency / European Commission / European Union / Pharmacovigilance Risk Assessment Committee / /

Position

Executive Director / Director / Director 20 February / Executive / reporter / /

Product

case documentation / /

URL

www.hma.eu / www.ema.europa.eu / /

SocialTag