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Details for article 13 of 15 found articles
| Title: |
Regulatory issues on pharmacovigilance in Latin American countries |
| Author: |
Olivera, María Eugenia Uema, Sonia Andrea Naeko Romañuk, Carolina Beatriz Caffaratti, Mariana Mastroianni, Patricia Carvalho Varallo, Fabiana Rossi Vazquez, Marta Fagiolino, Pietro Maldonado, Cecilia Vega, Elena María Galvan, Zully Vera Maidanag, Mabel Acostag, Patricia Rivero, Roxana Barros, Carolina Fontana, Daniela |
| Appeared in: |
Pharmaceuticals policy and law |
| Paging: | Volume 16 (2014) nr. 3-4 pages 289-312 |
| Year: |
2014-10-20 |
| Contents: |
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. |
| Publisher: |
IOS Press |
| Source file: |
Elektronische Wetenschappelijke Tijdschriften |
Details for article 13 of 15 found articles
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