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Optimising the Development of Paediatric Medicines
Session Chair(s)
Johannes Van den Anker
Professor, Department of Paediatric Pharmacology
Basel University Children's Hospital, Switzerland
This session will look at the learnings of the first 10 years of the Paediatric Regulation for the development of paediatric medicines (formulation, toxicology, clinical development) and discuss how we can draw from this learnings and see what the next 10 years may bring.
Learning Objective : • Identify regulatory guidance for extrapolation in pediatric/rare diseases; interpret the details of this process through specific examples • Apply this information to predict whether a given disease and drug can use full extrapolation, partial extrapolation, or no extrapolation • Discriminate that this process is dynamic, requiring updating and revision based on relevant emerging information
Speaker(s)
Extrapolating Efficacy and Safety for Pediatric/Rare/Orphan Diseases: Adult Data, Drug and Disease, Modeling and Simulation
Thomas Allen Laage, MD, MPH
Premier Research, United States
Senior Medical Director
Updates on Nonclinical Development of Pediatric Drugs
Beatriz Silva Lima, PharmD, PhD
University of Lisbon, Portugal
Director of FFUL, Faculty of Pharmacy
Age-Appropriate and Acceptable Paediatric Dosage Forms: Making Medicines Child Size
Roy Turner, PhD, MSc
Actelion, Switzerland
Technical Project Leader, Drug Product Operations
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