Director of Epidemiology
Teva Pharmaceutical Industries Ltd, Israel
Dr. Sigal Kaplan brings more than 25 years of regulatory and pharmaceutical industry experience in pharmaccoepidemiology with strong expertise in safety assessment, risk management, real world data and registries. She is Director, Pharmacoepidemiology Leader in in Teva since December 2012 with oversight and leadership of global post-marketing requirements and post authorization safety studies from start-up to publication. She is instrumental in guiding the emerging use of RWE for regulatory decision-making across functional areas, and designing epidemiologic and risk minimization strategies for regulatory submission. She is responsible for various therapeutic areas, including neurology, migraine, respiratory, oncology and women’s health. Prior to joining Teva, she served as a senior pharmacoepidemiology leader for 7 years in the Office of Surveillance and Epidemiology (OSE) at the US Food and Drug Administration (FDA). In this capacity, she led a team of epidemiologists, overseeing the team activities in the Division of all epidemiological reviews. She also reviewed and designed pharmacoepidemiological studies using RWD for medicines regulation from various healthcare databases with data service partners contracted with FDA.
Dr. Kaplan received her PhD degree in Pharmaceutical Health Services Research majoring in pharmacoepidemiology from University of Maryland, USA. She also holds a B.Pharm degree in Pharmacy from the Hebrew University in Jerusalem.
