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Omni Shoreham Hotel

Jan 27, 2019 9:00 AM - Jan 27, 2019 5:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Short Course 1: Introduction to Pharmacoepidemiology

Instructors

Adebola O Ajao

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

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

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, PHD, FISPE

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

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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