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Session 2B Oncology Paediatric Development: Learning from Experience
Session Chair(s)
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France
Through two case examples (nilotinib in chronic myeloid leukaemia (CML), and selumetinib for neurofibroma and glioma), the session will be an opportunity to share learnings and to understand how two different companies are developing paediatric plans having in mind the final objective, which is to facilitate children’s access to important medicines while addressing important medical needs. In addition, the use of physiologically based pharmacokinetic (PBPK) modelling to support paediatric development will also be addressed.
Speaker(s)
Meike Angstenberger, PhD
Novartis Pharma AG, Switzerland
Senior Global Program Regulatory Manager, RA Oncology
ONCOLOGY PAEDIATRIC DEVELOPMENT: LEARNING FROM EXPERIENCE
George Kirk, PhD
AstraZeneca, United Kingdom
Global Medicines Lead
ONCOLOGY PAEDIATRIC DEVELOPMENT: LEARNING FROM EXPERIENCE
Amy S. Y. Cheung, PhD
AstraZeneca, United Kingdom
Senior Pharmacometrician, Early Clinical Development
Hubert Caron, DrMed, MSc
F.Hoffmann- La Roche Ltd, Switzerland
Medical Director
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