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http://www.clarin.com/sociedad/salud/Glaxo-decide-multas-ensayos-clinicos_0_682731861.html
Spanish-English translation
Glaxo decided to pay fines for clinical trials in children
BY PAUL CALVO
The laboratory fails to appeal the sanction imposed by the ANMAT irregularities.
15/04/12
To "bring closure to the judicial process" and then not getting response from the Supreme Court, the international laboratory GlaxoSmithKline decided to pay millions in fines imposed by the State for irregularities in the recruitment of children in Argentina to test one of immunizations.
The case, Clarin brought to light in December 2007, forcing Argentina to improve legislation on clinical trials, which sonfundamentales for the advancement of science, but must now be done more carefully for the rights of patients.
Economic Criminal Judge Marcelo Aguinsky confirmed that the company already announced its decision to appeal the sanctions decided by the National Drug, Food and Medical Technology (ANMAT) and that payment of the final sum came "under implementation" .
The agency applied three fines of one million pesos each, because the testing was done in three provinces: Santiago del Estero, Mendoza and San Juan. In each case, the laboratory was passed and two of his investigators. The fault-established Justice and the administrative authority, occurred in the area of "informed consent" crucial stage in which to put the risks of both parents of the children involved.
The aim of the laboratory was included in the study Compas to 17 thousand children, but the uptake was interrupted by anomalies "administrative and procedural" and the work was done with 13,981 children in the country. The vaccine against pneumonia and otitis media was finally passed, while regulations were issued to improve information on the tests.
Spanish-English translation
Glaxo decided to pay fines for clinical trials in children
BY PAUL CALVO
The laboratory fails to appeal the sanction imposed by the ANMAT irregularities.
15/04/12
To "bring closure to the judicial process" and then not getting response from the Supreme Court, the international laboratory GlaxoSmithKline decided to pay millions in fines imposed by the State for irregularities in the recruitment of children in Argentina to test one of immunizations.
The case, Clarin brought to light in December 2007, forcing Argentina to improve legislation on clinical trials, which sonfundamentales for the advancement of science, but must now be done more carefully for the rights of patients.
Economic Criminal Judge Marcelo Aguinsky confirmed that the company already announced its decision to appeal the sanctions decided by the National Drug, Food and Medical Technology (ANMAT) and that payment of the final sum came "under implementation" .
The agency applied three fines of one million pesos each, because the testing was done in three provinces: Santiago del Estero, Mendoza and San Juan. In each case, the laboratory was passed and two of his investigators. The fault-established Justice and the administrative authority, occurred in the area of "informed consent" crucial stage in which to put the risks of both parents of the children involved.
The aim of the laboratory was included in the study Compas to 17 thousand children, but the uptake was interrupted by anomalies "administrative and procedural" and the work was done with 13,981 children in the country. The vaccine against pneumonia and otitis media was finally passed, while regulations were issued to improve information on the tests.