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Use of Extrapolation in Paediatric Drug Development: Can We Achieve Global Agreement through the Revision of the ICH E11 Paediatric Guideline?
Session Chair(s)
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France
Since 2012, when the EMA issued their concept paper on extrapolation of efficacy and safety in medicine development, the interest in the appropriate use of extrapolation in paediatrics has increased. Along with this, the revision of the ICH E11 paediatric guideline has started at the global level. A systematic approach to extrapolation including use of prior knowledge is key for any paediatric development strategy when extrapolation is considered. How to conduct high quality and ethical research without subjecting children to unnecessary studies? How to appropriately develop a new medicine so that children in need can access it in a timely manner? Is it possible to successfully complete a global paediatric development plan? This session will address these questions through case examples and at the light of the EMA draft extrapolation Reflection Paper which should be released soon.
Speaker(s)
Robert Hemmings, MSc
Critical Path Institute, United States
Partner
Extrapolation in Paediatrics: The FDA Perspective
Lynne Yao, MD
FDA, United States
Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER
Extrapolation in Paediatrics: A Developer Perspective
Samuel Maldonado, MD, MPH
Janssen Research & Development, LLC , United States
Vice President, Head of Child Health Innovation Leadership Department
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