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Session Chair(s)
Dinah Duarte, MSC
Signal Management Lead
European Medicines Agency, Netherlands
Learning Objective : Discuss the importance of nonclinical juvenile animal guidance in pediatric drug development; Share real world experience from available historical data on juvenile animal studies; Examine if juvenile animal studies in nonclinical support for pediatric drug development has significantly changed.
Speaker(s)
Juvenile Animal Studies and Pediatric Nonclinical Development: EU Perspective
Dinah Duarte, MSC
European Medicines Agency, Netherlands
Signal Management Lead
Juvenile Animal Studies and Pediatric Nonclinical Development: Industry Perspective
Mark E Hurtt, PHD
Pfizer Inc, United States
Executive Director and Global Head, DSRD Centers of Emphasis
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