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