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Gita A. Toyserkani, PharmD, MBA

Associate Director for Research and Strategic Initiatives
US Food and Drug Administration
Silver Spring, United States

Dr. Gita Toyserkani is the Associate Director for Research and Strategic Initiatives in FDA’s Office of Medication Error Prevention and Risk Management (OMEPRM), in the Office of Surveillance and Epidemiology (OSE) within FDA’s Center for Drug Evaluation and Research (CDER). She has over 20 years of experience in drug safety, pharmacovigilance, and risk management. She advises on pre- and post-market activities and policies involving risk management for products regulated by CDER. In her current role, she overseas research activities related to advancing the science of risk management, risk communication, and risk assessment. Her area of interest has been applying implementation science and use of frameworks for designing, implementing, and evaluating Risk Evaluation and Mitigtation Strategy (REMS) programs.

During her tenure at FDA, Gita has been extensively involved in key guidances on risk management and led various REMS standardization initiatives including developing a framework for linking REMS program design with assessment, REMS document standardization, REMS Integration and SPL, leveraging the use of Drug Master Files for shared system REMS, and the development of the REMS Public Dashboard. She has given numerous presentations and talks on wide range of topics and authored many important papers on topics in risk management.

Gita received her Pharm.D. from University of Maryland School of Pharmacy and her MBA from the University of Baltimore, Merrick School of Business with a concentration in health care management.

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