dc.creator | Olivera, Maria Eugenia | |
dc.creator | Uema, Sonia Andrea Naeko | |
dc.creator | Romañuk, Carolina Beatriz | |
dc.creator | Caffaratti, Marina | |
dc.creator | Carvalho Mastroianni, Patricia | |
dc.creator | Rossi Varallo, Fabiana | |
dc.creator | Vazquez, Marta | |
dc.creator | Fagiolino, Pietro | |
dc.creator | Maldonado, Cecilia | |
dc.creator | Vega, Elena Maria | |
dc.creator | Vera Galvan, Zully | |
dc.creator | Maidanag, Mabel | |
dc.creator | Acostag, Patricia | |
dc.creator | Rivero, Roxana | |
dc.creator | Barros, Carolina | |
dc.creator | Fontana, Daniela | |
dc.date.accessioned | 2018-01-18T14:14:15Z | |
dc.date.available | 2018-01-18T14:14:15Z | |
dc.date.created | 2018-01-18T14:14:15Z | |
dc.date.issued | 2014-10 | |
dc.identifier | Olivera, 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.identifier | 1389-2827 | |
dc.identifier | http://hdl.handle.net/11336/33749 | |
dc.identifier | CONICET Digital | |
dc.identifier | CONICET | |
dc.description.abstract | Pharmacovigilance 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.language | eng | |
dc.publisher | IOS Press | |
dc.relation | info:eu-repo/semantics/altIdentifier/doi/http://dx.doi.org/10.3233/PPL-140390 | |
dc.relation | info:eu-repo/semantics/altIdentifier/url/https://content.iospress.com/articles/pharmaceuticals-policy-and-law/ppl00390 | |
dc.rights | https://creativecommons.org/licenses/by-nc-sa/2.5/ar/ | |
dc.rights | info:eu-repo/semantics/restrictedAccess | |
dc.subject | Drug Information Services | |
dc.subject | Product Surveillance | |
dc.subject | Postmarketing | |
dc.subject | Pharmaceutical Industry | |
dc.subject | Public Health | |
dc.title | Regulatory issues on pharmacovigilance in Latin American countries | |
dc.type | info:eu-repo/semantics/article | |
dc.type | info:ar-repo/semantics/artículo | |
dc.type | info:eu-repo/semantics/publishedVersion | |