Regulatory issues on pharmacovigilance in Latin American countries

dc.creatorOlivera, Maria Eugenia
dc.creatorUema, Sonia Andrea Naeko
dc.creatorRomañuk, Carolina Beatriz
dc.creatorCaffaratti, Marina
dc.creatorCarvalho Mastroianni, Patricia
dc.creatorRossi Varallo, Fabiana
dc.creatorVazquez, Marta
dc.creatorFagiolino, Pietro
dc.creatorMaldonado, Cecilia
dc.creatorVega, Elena Maria
dc.creatorVera Galvan, Zully
dc.creatorMaidanag, Mabel
dc.creatorAcostag, Patricia
dc.creatorRivero, Roxana
dc.creatorBarros, Carolina
dc.creatorFontana, Daniela
dc.date.accessioned2018-01-18T14:14:15Z
dc.date.available2018-01-18T14:14:15Z
dc.date.created2018-01-18T14:14:15Z
dc.date.issued2014-10
dc.identifierOlivera, Maria Eugenia; Uema, Sonia Andrea Naeko; Romañuk, Carolina Beatriz; Caffaratti, Marina; Carvalho Mastroianni, Patricia; et al.; Regulatory issues on pharmacovigilance in Latin American countries; IOS Press; Pharmaceuticals Policy and Law; 16; 3-4; 10-2014; 289-312
dc.identifier1389-2827
dc.identifierhttp://hdl.handle.net/11336/33749
dc.identifierCONICET Digital
dc.identifierCONICET
dc.description.abstractPharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during 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. The active rol of the universities and drug information centers for/of pharmacovilance seems to be a positive common point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a point to be developed.
dc.languageeng
dc.publisherIOS Press
dc.relationinfo:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.3233/PPL-140390
dc.relationinfo:eu-repo/semantics/altIdentifier/url/https://content.iospress.com/articles/pharmaceuticals-policy-and-law/ppl00390
dc.rightshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.rightsinfo:eu-repo/semantics/restrictedAccess
dc.subjectDrug Information Services
dc.subjectProduct Surveillance
dc.subjectPostmarketing
dc.subjectPharmaceutical Industry
dc.subjectPublic Health
dc.titleRegulatory issues on pharmacovigilance in Latin American countries
dc.typeinfo:eu-repo/semantics/article
dc.typeinfo:ar-repo/semantics/artículo
dc.typeinfo:eu-repo/semantics/publishedVersion


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