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Session Chair(s)
Celine Adessi, PHD
Senior Clinical Safety Scientist
F. Hoffmann - La Roche, Switzerland
Learning Objective : Identify gaps in managing human risk of drugs inducing non-monitorable toxicology findings in animals; Evaluate alternative approaches in refining animal testing for human health risk assessment; Discuss the importance of nonclinical juvenile animal guidance in pediatric drug development.
Speaker(s)
Drug-induced Vasculitis: A Non Monitorable Toxicology Finding and A Dilemma in Translational Medicine
Celine Adessi, PHD
F. Hoffmann - La Roche, Switzerland
Senior Clinical Safety Scientist
Nonclinical Assessment of Blood Pressure Changes: Challenges, New Technologies and Translation to Human
Andrea Greiter-Wilke, DVM, PHD
F. Hoffmann-La Roche AG, Switzerland
Head, Safety Pharmacology
Juvenile Animal Studies and Pediatric Drug Development: Systematic or Case-by-case?
Dinah Duarte, MSC
European Medicines Agency, Netherlands
Signal Management Lead
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