Impact of the Nonclinical Juvenile Animal Studies on Pediatric Medicines Information

Time

Tue, Jun 16 9:00AM
T 06

Title

Impact of the Nonclinical Juvenile Animal Studies on Pediatric Medicines Information

Abstract Summary

Critical and retrospective analysis of European Medicines Agency (EMA) data about existence, number and design of JAS, paediatric indication and species - in the labelling of all approved European Public Assessment Reports and Summary of Medicine Product Characteristics (2007-2014).

Poster Presenter

Dinah Duarte
PharmD, MSc,
Head, Scientific Evaluation Unit, Directorate of Medicinal Products,
INFARMED
Portugal