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SESSION 5: INNOVATIVE PAEDIATRIC PLAN DESIGN
Session Chair(s)
Efthymios Manolis, PharmD, MSc
Scientific Administrator
European Medicines Agency, Netherlands
Facilitating Data-Sharing
Speaker(s)
What Can We Learn from Failed Paediatric Trials?
Gilbert J Burckart
FDA, United States
Associate Director for pediatrics
Extrapolation
Oscar Della Pasqua, MD
University College London, United Kingdom
Chair Clinical Pharmacology & Therapeutics
Clinical Trial Design/Modelling and Simulation – new approaches in ICH E11
Solange Corriol-Rohou, DrMed, MD, PhD
AstraZeneca , France
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
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