Gita A. Toyserkani, PharmD, MBA, is the Associate Director for Research and Strategic Initiatives in the Division of Risk Management in FDA’s Office of Surveillance and Epidemiology. She has over 15 years of experience in drug safety and advises on pre and post-marketing activities and policies involving REMS for products regulated by CDER. In her current role, Dr. Toyserkani overseas research activities related to risk minimization. Dr. Toyserkani has led several REMS standardization efforts and initiatives to advance the science of risk minimization. Her career at FDA started in 2005 as a Safety Evaluator in the Division of Pharmacovigilance. Prior to FDA, she was a clinical pharmacist at Walter Reed National Military Medical Center.