EFGCP Better Medicines for Children Pre-Conference
The Fundamentals of Paediatric Extrapolation
|Date(s)||17 Oct. 2022|
|Duration||4 hours/ day|
In Spring 2022, the International Council for Harmonization (ICH) published the E11A draft guideline establishing a framework for extrapolation from existing data to the pediatric population. The new guideline aims to promote international harmonization of methodologies and strategies to incorporate pediatric extrapolation into overall drug development plans, improving the speed of access to new drugs for pediatric patients while limiting the number of children required for enrolment in clinical trials. The extrapolation framework consists of a pediatric extrapolation concept, and the creation and execution of an extrapolation plan.
This workshop has been designed to provide pediatric researchers, trial sponsors, and regulatory reviewers an opportunity to actively engage with experts to learn the fundamentals of developing a pediatric extrapolation concept and plan.
Attendees will participate in interactive small group discussions learning how to assess the similarities and differences of disease between a reference and a target population. Experts will also guide attendees through the development of an extrapolation plan - determining the relevant studies to be performed, analyzing whether model-informed approaches are appropriate and evaluating potential study designs. Workshop attendees will learn about the use of bridging biomarkers, Bayesian strategies and single arm pharmacokinetic/pharmacodynamic (PK/PD) studies and their application in pediatric extrapolation.
|13:00||Opening of Conference|
|13:00||Welcome and Introduction to the pre-Conference Workshop|
|13:55||Introduction of the Breakout Sessions|
|14:00||Breakout Session 1 - "Developing the Extrapolation Concept"|
|14:55||Breakout Session 2 - "Developing the Extrapolation Plan"|
|15:40||Parting Comments & Key Take-aways|
|16:00||End of the Conference|