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Session 5 Continued
Session Chair(s)
Janina Karres, PHD
Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands
Roberto De Lisa, MD
Scientific Officer, Paediatric Medicines Office
European Medicines Agency, Netherlands
Speaker(s)
ICH S11 Guideline
Georg Schmitt, PHD
Roche Pharma Research and Early Development, F. Hoffmann-La Roche Ltd, Switzerland
Head Toxicology (Operations) and Nonclinical Paediatrics
Revision of the ICH E11 Guideline
Solange Corriol-Rohou, DrMed, MD, PHD
SCR Consulting, France
IMI2: Pan European Paediatric Clinical Trials Network
Heidrun Hildebrand
BAYER, Germany
Paediatric Development Alliance Manager, Paediatric Medicine; Research and De
IMI2: Paediatric Preclinical Proof of Concept (POC) Platform
Stefan Pfister , MD
German Cancer Research Center (DKFZ) Heidelberg, Germany
Head of Division Paediatric Neurooncology
The FP7 Advances in Small Trials dEsign for Regulatory Innovation and eXcellence (ASTERIX) project
Kit B. Roes, PHD
University Medical Center Utrecht, Netherlands
Professor of Clinical Trial Methdology
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