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NH SCHIPHOL AIRPORT

Sep 16, 2019 8:00 AM - Sep 17, 2019 5:00 PM

Kruisweg 495 , 2132 NA Hoofddorp , Netherlands

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

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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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Better Medicines for Children, A DIA/EFGCP Conference

Session 6: Nonclinical Studies to Support Paediatric Drug Development

Session Chair(s)

To Be Announced

Mette Due Theilade Thomsen, PhD

Speaker(s)

Industry Perspective

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

Update on PDCO Juvenile Animal Study Projects

Preclinical Disease Models for Nonclinical Pharmacology Data on Drugs

Industry Perspective

Be informed and stay engaged.