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Session 6: Nonclinical Studies to Support Paediatric Drug Development
Session Chair(s)
To Be Announced
NA, Switzerland
Mette Due Theilade Thomsen, PhD
CEO
PIP Adviser, Denmark
Session 6: Nonclinical Studies to Support Paediatric Drug Development
Speaker(s)
Industry Perspective
Invited Speaker
Switzerland
ICH S11 (Nonclinical Safety Testing in Support of Development of Paediatric Medicines)
David Jones, MS
ApconiX, United Kingdom
Consultant, Regulatory Pharmaco-Toxicologist
Update on PDCO Juvenile Animal Study Projects
Karen Van Malderen
Agence Fédérale des Médicaments et des Produits de Santé, Belgium
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
Preclinical Disease Models for Nonclinical Pharmacology Data on Drugs
Ralph Bax, MD, PhD
European Medicines Agency, Netherlands
Head of the Paediatric Medicines Office
Industry Perspective
Andreas Hartmann, PhD
Novartis Pharma, Switzerland
Executive Director
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