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Please use this identifier to cite or link to this item: http://acervodigital.unesp.br/handle/11449/133808
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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-
dc.contributor.authorVarallo, Fabiana Rossi-
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.date.accessioned2016-01-28T16:56:41Z-
dc.date.accessioned2016-10-25T21:28:56Z-
dc.date.available2016-01-28T16:56:41Z-
dc.date.available2016-10-25T21:28:56Z-
dc.date.issued2014-
dc.identifierhttp://dx.doi.org/10.3233/PPL-140390-
dc.identifier.citationPharmaceuticals Policy and Law, v. 16, p. 289-312, 2014.-
dc.identifier.issn1389-2827-
dc.identifier.urihttp://hdl.handle.net/11449/133808-
dc.identifier.urihttp://acervodigital.unesp.br/handle/11449/133808-
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.format.extent289-312-
dc.language.isoeng-
dc.publisherNetwork of Centres for Study of Pharmaceutical Law-
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.typeoutro-
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.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.identifier.doi10.3233/PPL-140390-
dc.rights.accessRightsAcesso restrito-
dc.relation.ispartofPharmaceuticals Policy and Law-
dc.identifier.lattes4160558780902988-
Appears in Collections:Artigos, TCCs, Teses e Dissertações da Unesp

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