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Short Course 1: Introduction to Pharmacoepidemiology


Instructors

  • Adebola O Ajao

    Adebola O Ajao

    • Epidemiologist
    • FDA/CDER, 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

    Veronica V Sansing Foster

    • Epidemiologist
    • 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

    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

    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, FISPE

    Annette Stemhagen, DrPH, FISPE

    • Senior Vice President and Chief Scientific Officer
    • UBC, United States

    Dr. Stemhagen is an epidemiologist with over 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management and Chief Scientific Officer at UBC, where she provides strategic consultative services to Sponsors, particularly in the areas of REMS, observational studies and RWE. Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, Risk Evaluation and Mitigation Strategies (REMS) registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval.

  • Danijela  Stojanovic, PharmD

    Danijela Stojanovic, PharmD

    • Research Officer, OSE, CDER
    • FDA, United States

    Danijela Stojanovic is an epidemiologist on the Sentinel Core Team in FDA’s Office of Surveillance and Epidemiology. Her background is multidisciplinary, including prospective cohorts, administrative claims data, pharmacoepi methods, pharmacovigilance, and clinical pharmacy. She has been at FDA since 2014 and worked in the Divisions of Pharmacovigilance and Epidemiology. Dr. Stojanovic has a BS in Chemistry and a PharmD from the University of Texas and a PhD in pharmacoepidemiology from the University of Florida.