Charles Schmidt
FCMSCSP, Brazil
Title: Recently developments for regulatory clinical trial approvals in Brazil
Biography
Biography: Charles Schmidt
Abstract
In the last 2 years Brazil has taken some actions to improve the timeline and quality for regulatory approvals in clinical trials. The Local Health Authority – ANVISA issue 2 new regulations for this process that also involves bio-similar and medical devices. The efforts has been showing some results, nevertheless adjusts has to be taken to increase transparence and reliable process for those procedures and also include better training of the ANVISA resources. At the same time the association- Brazil Alliance for Clinical Research (Aliança Pesquisa Clinica Brasil Clinica Brasil) worked with the Brazilian Senators to issue a new law for Clinical Research that is still in analyses by the government but it will be a landmark for the country and Latin America in this field. We intend to discuss those new initiatives and clarifying the audience that Brazil is moving to the right direction regarding regulation for clinical trials following better GCP, Bioethics and Human Rights.