Pharmacoepidemiology and Drug Safety Best Paper of 2022: Novel Methods for Pregnancy Drug Safety ‎Surveillance in the FDA Sentinel System

Pharmacoepidemiology and Drug Safety (PDS), the official journal of ISPE, presents the Ronald D. Mann ‎Best Paper Award each year to the strongest contribution within a given volume of the journal. The award ‎for 2022 is presented to Dr. Elizabeth A. Suarez and collaborators for their paper ”Novel Methods for ‎Pregnancy Drug Safety Surveillance in the FDA Sentinel System.”‎ The paper discussed the application of TreeScan™, a statistical data mining tool, within the FDA Sentinel ‎System to simultaneously identify multiple potential adverse neonatal and infant outcomes after ‎maternal medication exposure. This method could supplement existing approaches to enhance the ‎surveillance of medication safety during pregnancy.‎

In this webinar, Dr. Suarez presented findings of the study, followed by comments by PDS regional ‎editor for the Americas, Dr. Vincent Lo Re.