Pediatric pharmacovigilance in Brazil-South America
2nd International Conference and Exhibition on Pharmacovigilance & Clinical Trials
November 18-19, 2013 Hilton San Antonio Airport, TX, USA

Charles Schmidt

Accepted Abstracts: J Pharmacovigilance

Abstract:

Pediatric pharmacovigilance (PPV) is a neglected aspect around the world, specifically in emerging countries. In Brazil, it was created a system for PPV called - ?Hospital Sentinela? (Sentinel Hospital) in 2002 to capture pro-actively general ADR in the country and more recently in 2009 the ?NOTIVISA - today VIGIPOS? a web base system to collect AE and technical complains after product commercialization. Neither of those systems has dedicated procedures for PPV. Also health professionals were not usually trained on PPV in the Latin America. We strongly encourage the establishment of pediatric drug safety networks worldwide and trainings (within healthcare institutions as well as regional, national and international networks) to better use the scarce resources and the adoption of more proactive drug safety evaluation initiatives to solve drug safety problems for children in a timely manner. As an example we would like to present the initiatives from a non-profit pediatric hospital (Hospital Sabara) in Sao Paulo/Brazil and its results in PPV and how it could be a model for others hospitals in Latin America.

Biography :

Charles Schmidt is a Pediatrician with master's and Doctorate degree in Pediatric Infectious Disease at Sao Paulo Federal University and postgraduated in management for non-profit organizations at Sao Paulo State University. He has more than 22 years of experience in clinical research in academic environment, pharmaceutical industries and CROs in Latin America. He is responsible for the post-graduation program in clinical research at Santa Casa Medical School in Sao Paulo. He is the founder and ex-president of the Brazilian Association of CROs (ABRACRO), member of the board of the Brazilian Association of Pharmaceutical Physicians (SBMF), and member of the DIA Steering Committee for Latin America.