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Regulatory issues on pharmacovigilance in Latin American countries

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dc.contributor.authorOlivera, María Eugenia
dc.contributor.authorUema, Sonia Andrea Naeko
dc.contributor.authorRomañuk, Carolina Beatriz
dc.contributor.authorCaffaratti, Mariana
dc.contributor.authorMastroianni, Patricia de Carvalho [UNESP]
dc.contributor.authorVarallo, Fabiana Rossi [UNESP]
dc.contributor.authorVazquez, Marta
dc.contributor.authorFagiolino, Pietro
dc.contributor.authorMaldonado, Cecilia
dc.contributor.authorVega, Elena María
dc.contributor.authorGalvan, Zully Vera
dc.contributor.authorMaidanag, Mabel
dc.contributor.authorAcostag, Patricia
dc.contributor.authorRivero, Roxana
dc.contributor.authorBarros, Carolina
dc.contributor.authorFontana, Daniela
dc.contributor.institutionUniversidad Nacional de Córdoba
dc.contributor.institutionUniversidade Estadual Paulista (Unesp)
dc.contributor.institutionUniversidad de la República
dc.contributor.institutionUniversidad de Chile
dc.contributor.institutionUniversidad de Assunción
dc.date.accessioned2016-01-28T16:56:41Z
dc.date.available2016-01-28T16:56:41Z
dc.date.issued2014
dc.description.abstractPharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.en
dc.description.affiliationUniversidad Nacional de Córdoba, Facultad de Ciencias Químicas, Departamento de Farmacia, Argentina
dc.description.affiliationUniversidad Nacional de Córdoba, Facultad de Ciencias Químicas, Departamento de Farmacia, Unidad de Investigación y Desarrollo, Argentina
dc.description.affiliationUniversidad Nacional de Córdoba, Facultad de Ciencias Químicas, Centro de Información de Medicamentos, Argentina
dc.description.affiliationUniversidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Faculdade de Ciências Farmacêuticas de Araraquara (FCFAR), Departamento de Fármacos e Medicamentos, Rodovia Araraquara/Jaú, km 1, Campus, CEP 14801902, Araraquara, SP, Brasil
dc.description.affiliationUniversidad de la República, Facultad de Química, Departamento de Ciencias Farmacéuticas, Montevideo, Uruguay
dc.description.affiliationUniversidad de Chile, Facultad de Ciencias Químicas y Farmacéuticas, Departamento de Ciencias e Tecnología Farmacéuticas, Santiago, Chile
dc.description.affiliationUniversidad Nacional de Assunción, Facultad de Ciencias Químicas, Assunción, Paraguay
dc.description.affiliationUniversidad Nacional de Córdoba, Departamento de Farmacoepidemiología e Información Científica, Laboratorio de Hemoderivados, Argentina
dc.description.affiliationUnespUniversidade Estadual Paulista Júlio de Mesquita Filho (UNESP), Faculdade de Ciências Farmacêuticas de Araraquara (FCFAR), Departamento de Fármacos e Medicamentos, Rodovia Araraquara/Jaú, km 1, Campus, CEP 14801902, Araraquara, SP, Brasil
dc.format.extent289-312
dc.identifierhttp://dx.doi.org/10.3233/PPL-140390
dc.identifier.citationPharmaceuticals Policy and Law, v. 16, p. 289-312, 2014.
dc.identifier.doi10.3233/PPL-140390
dc.identifier.issn1389-2827
dc.identifier.lattes4160558780902988
dc.identifier.orcid0000-0001-8467-7278
dc.identifier.urihttp://hdl.handle.net/11449/133808
dc.language.isoeng
dc.publisherNetwork of Centres for Study of Pharmaceutical Law
dc.relation.ispartofPharmaceuticals Policy and Law
dc.relation.ispartofsjr0,102
dc.rights.accessRightsAcesso restritopt
dc.sourceCurrículo Lattes
dc.subjectDrug information servicesen
dc.subjectProduct surveillanceen
dc.subjectPostmarketingen
dc.subjectPharmaceutical industryen
dc.subjectPub-lic healthen
dc.titleRegulatory issues on pharmacovigilance in Latin American countriesen
dc.typeArtigopt
dcterms.rightsHolderNetwork of Centres for Study of Pharmaceutical Law
dspace.entity.typePublication
relation.isDepartmentOfPublicatione214da1b-9929-4ae9-b8fd-655e9bfeda4b
relation.isDepartmentOfPublication.latestForDiscoverye214da1b-9929-4ae9-b8fd-655e9bfeda4b
relation.isOrgUnitOfPublication95697b0b-8977-4af6-88d5-c29c80b5ee92
relation.isOrgUnitOfPublication.latestForDiscovery95697b0b-8977-4af6-88d5-c29c80b5ee92
unesp.author.lattes4160558780902988[5]
unesp.author.orcid0000-0001-8467-7278[5]
unesp.campusUniversidade Estadual Paulista (UNESP), Faculdade de Ciências Farmacêuticas, Araraquarapt
unesp.departmentFármacos e Medicamentos - FCFpt

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Coleções

Araraquara - FCF - Faculdade de Ciências Farmacêuticas