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Better Medicines for Children, A DIA/EFGCP Conference

Plan ahead and join us to reflect on the importance of two major headways that are currently affecting Paediatric research: Innovative approaches to Drug Development and impact of the current environment on the Regulatory and Research Infrastructure


Session 6: Nonclinical Studies to Support Paediatric Drug Development

Session Chair(s)

Mette  Due Theilade Thomsen, PhD

Mette Due Theilade Thomsen, PhD

  • Managing Director
  • PIP Adviser, Denmark
  Session Chair

Session Chair

  • France
Session 6: Nonclinical Studies to Support Paediatric Drug Development

Speaker(s)

Invited  Speaker

Industry Perspective

Invited Speaker

  • DIA, Switzerland
David  Jones, MS

ICH S11 (Nonclinical Safety Testing in Support of Development of Paediatric Medicines)

David Jones, MS

  • Expert Pharmacotoxicologist, Clinical Trials Unit
  • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Karen  Van Malderen

Update on PDCO Juvenile Animal Study Projects

Karen Van Malderen

  • Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten
  • Agence Fédérale des Médicaments et des Produits de Santé, Belgium
Ralph  Bax, MD, PhD

Preclinical Disease Models for Nonclinical Pharmacology Data on Drugs

Ralph Bax, MD, PhD

  • Head of the Paediatric Medicines Office
  • European Medicines Agency, Netherlands
Andreas  Hartmann, PhD

Industry Perspective

Andreas Hartmann, PhD

  • Executive Director
  • Novartis Pharma, Switzerland

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