Instructors
Adebola O Ajao
Epidemiologist, CDER, FDA, United States
Dr. Ajao is a pharmacoepidemiologist within FDA’s Office of Surveillance and Epidemiology. Dr. Ajao’s expertise is in post-marketing surveillance of pharmaceutical products. Dr. Ajao applies epidemiology principles and analytical methods to assess the effects of pharmaceuticals on different health outcomes. Dr. Ajao’s background is in microbiology, infectious diseases, reproductive health, and health policy. She received a BS in Microbiology from Purdue University, an MPH in Epidemiology and Biostatistics from Boston University, and a PhD in Molecular Epidemiology from the University of Maryland Baltimore. Her previous work included developing federal policies on stockpiling pharmaceuticals for large scale public health emergencies.
Veronica V Sansing Foster
Epidemiologist, CDER, FDA/CDER, United States
Dr. Veronica Sansing-Foster is an epidemiologist at the Food and Drug Administration’s Office of Surveillance and Epidemiology. Dr. Sansing-Foster began her career at FDA in 2010 where she worked as an Acting Branch Chief and Lead Epidemiologist at the Center for Devices and Radiological Health (CDRH). Dr. Sansing-Foster progressed over to FDA's Center for Drug Evaluation and Research (CDER) in 2014. In her current position,she proposes,designs,implements, and analyzes epidemiological data for anti-infective and antiviral medications,medications for cardio-renal pulmonary diseases,and asthma medications.
Efe Eworuke
Epidemiologist, FDA, United States
Efe Eworuke B.Pharm, MSc., PhD is a Lead Epidemiologist for the Division of Epidemiology in the Office of Pharmacovigilance and Epidemiology, Office of Surveillance and Epidemiology. Efe leads the epidemiology team that oversees safety evaluations that cover cardiovascular, renal, pulmonary, rheumatology and allergy therapeutic products. Her research interests include pharamacoepidemiologic methods addressing confounding, quantitative bias methods, validation of study outcomes and pregnancy studies.
Lisa Melanie Harinstein, PHARMD
Team Leader, Division of Pharmacovigilance, FDA, FDA, United States
Lisa Harinstein is a Team Leader in the FDA-CDER Division of Pharmacovigilance. She received her Doctor of Pharmacy degree from the University of Michigan and completed a Pharmacy Practice and Critical Care Residency at the University of Pittsburgh Medical Center. She worked as a Surgical ICU Clinical Specialist at Cleveland Clinic prior to working at the FDA.
Annette Stemhagen, DrPH, PHD, FISPE
Chief Science Officer, UBC, United States
Dr. Annette Stemhagen is an epidemiologist, with >30 years of public health research experience, including 20+ years in the biopharmaceutical industry. She provides strategic consulting in epidemiology, pharmacovigilance, and risk management. She develops and implements creative and innovative epidemiologic study design solutions. She also has extensive expertise designing and implementing risk intervention programs, risk management evaluation studies, Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products. She was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.
Danijela Stojanovic, PHARMD, PHD
Clinical Analyst, OTBB, OND, CDER, FDA, United States
CDR Danijela Stojanovic is a clinical analyst in the Office of Therapeutic Biologics and Biosimilars at FDA's Center for Drug Evaluation and Research. Since joining the FDA in 2014, she has served in multiple roles, including safety reviewer, epidemiologist, and international science policy analyst, contributing to global regulatory science policy. Her work has focused on real-world evidence generation and multidisciplinary collaboration across regulatory and public health domains. She brings a comprehensive perspective on drug safety evaluation, integrating clinical, epidemiologic, and policy expertise.
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