About me
Donna R. Rivera, PharmD., MSc., FISPE is the Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence at the U.S. Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the regulatory review of Real World Data (RWD) and RWE in oncology across CDER, CBER, and CDRH, management of the RWD regulatory science research portfolio strategy, engagement and educational programs, and development of regulatory policy to support the OCE mission. As a pharmacist and pharmacoepidemiologist, Dr. Rivera has interests in applications of artificial intelligence in learning healthcare, pragmatic study designs and novel methodological approaches, and appropriate uses of RWD for drug development
