Publication:
Realizing a Regional Approach to Pharmacovigilance: A Review of the European Union Approach

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dc.contributor.authorWang, Huihui
dc.contributor.authorMarquez, Patricio V.
dc.contributor.authorBieliaieva, Kseniya
dc.date.accessioned2023-08-11T15:02:29Z
dc.date.available2023-08-11T15:02:29Z
dc.date.issued2023-08-11
dc.description.abstractThis report reviews the pharmacovigilance system of the European Union (EU) mapping out its structure and processes with any eye to features that may be of particular interest to decision makers in other regions as they weigh options related to creating a regional pharmacovigilance architecture for themselves. It begins with a review of the European Medicines Agency (EMA), which plays a central role in the EU system, followed by an overview of the EU PV assessment and monitoring process and an example of the system in action regarding COVID-19 vaccines. It concludes with a summary several key insights of particular relevance for decision makers.en
dc.identifierhttp://documents.worldbank.org/curated/en/099717408102335529/IDU08fbc09920371304d9409b77068510e557770
dc.identifier.doi10.1596/40178
dc.identifier.urihttps://openknowledge.worldbank.org/handle/10986/40178
dc.languageEnglish
dc.language.isoen_US
dc.publisherWashington, DC: World Bank
dc.relation.ispartofseriesPharmacovigilance and Essential Public Health Services Series
dc.rightsCC BY-NC 3.0 IGO
dc.rights.holderWorld Bank
dc.rights.urihttps://creativecommons.org/licenses/by-nc/3.0/igo
dc.subjectEMA
dc.subjectPHARMACOVIGILANCE
dc.subjectCOVID-19 VACCINES
dc.titleRealizing a Regional Approach to Pharmacovigilanceen
dc.title.subtitleA Review of the European Union Approachen
dc.typeReport
dspace.entity.typePublication
okr.crossref.titleRealizing a Regional Approach to Pharmacovigilance: A Review of the European Union Approach
okr.date.disclosure2023-08-11
okr.date.lastmodified2023-08-11T00:00:00Zen
okr.doctypeEconomic & Sector Work
okr.doctypeEconomic & Sector Work::Other Health Study
okr.docurlhttp://documents.worldbank.org/curated/en/099717408102335529/IDU08fbc09920371304d9409b77068510e557770
okr.guid099717408102335529
okr.identifier.docmidIDU-8fbc0992-3713-4d94-9b77-68510e557770
okr.identifier.doihttp://dx.doi.org/10.1596/40178
okr.identifier.externaldocumentum34133705
okr.identifier.internaldocumentum34133705
okr.identifier.report184488
okr.import.id1451
okr.importedtrueen
okr.language.supporteden
okr.pdfurlhttp://documents.worldbank.org/curated/en/099717408102335529/pdf/IDU08fbc09920371304d9409b77068510e557770.pdfen
okr.region.geographicalEurope
okr.sectorHealth-HG
okr.themeHealth Systems and Policies,Health Service Delivery,Pandemic Response,Health System Strengthening,Disease Control,Human Development and Gender,Health Systems and Policies,Adolescent Health,Child Health,Health System Strengthening,Health Service Delivery,Health Finance,Reproductive and Maternal Health,Private Sector Delivery in Health,Human Development and Gender
okr.topicHealth, Nutrition and Population::Health Policy and Management
okr.topicHealth, Nutrition and Population::Pharmaceuticals & Pharmacoeconomics
okr.unitHNP Global (HHNGE)
relation.isAuthorOfPublication601b45de-9e7b-5045-bfef-0689612779d8
relation.isAuthorOfPublication.latestForDiscovery601b45de-9e7b-5045-bfef-0689612779d8
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