PRA International has opened a Drug Safety Center in its São Paulo, Brazil office. Part of the company's safety and risk management unit, the center is responsible for serious adverse event and adverse drug reaction management. The drug safety center also supports clients with all other aspects of pharmacovigilance to help ensure regulatory compliance.
PRA currently operates two dedicated drug safety centers in Charlottesville, VA and Mannheim, Germany. The center in São Paulo adds to the company's presence in Latin America and provides additional global reporting capabilities. The safety and risk management team offers services throughout a product's life cycle. The company also provides services to support EU-RMP, FDA-REMS, annual safety reporting, IND reports and other services.
"The opening of the São Paulo Drug Safety Center enables us to expand our capabilities and level of service in Latin America and enhances our ability to provide standardized Drug Safety services globally, by growing and strengthening our overall safety team," noted Dr. Sabine Richter, PRA's vice president of safety and risk management. "This new center will allow us to create cost-effective and efficient global coverage that is enhanced with a local language and regulatory knowledge base. Both are key to our continued expansion of clinical trial and post-approval delivery in Latin America and globally."
Magazine
