EFGCP Better Medicines for Children Pre-Conference 2023

Dose optimization is integral to maximizing pediatric medicines development. Variability in pharmacokinetic and pharmacodynamic parameters across the pediatric population by size and/or age can increase the complexity associated with identifying the optimized dose for use of a new medicine. Understanding how to design and optimize selection of a pediatric dose leveraging existing data, employing dose-finding designs that maximize small patient numbers, or utilize quantitative approaches, is essential to maximizing safety, effectiveness and tolerability of new pediatric medicines.

This workshop has been designed to provide pediatric researchers, trial sponsors, and regulatory reviewers an opportunity to actively engage with experts on the fundamentals of developing a strategy for pediatric dose optimization.

Attendees will participate in interactive small group discussions utilizing case examples. Experts will guide attendees through the development of an anonymized pediatric dosing strategy utilizing two case examples – determining the relevance of available data for use in the pediatric program design, analysing whether model-informed approaches are appropriate, and/or evaluating and proposing study designs.

This event is complementary to the Better Medicines for Children Conference 2023, held in Brussels, Belgium on 17 & 18 October 2023. For more information on the Paediatric Conference 2023, see the EFGCP Better Medicines for Children Conference 2023 Webpage.

Event Format: Virtual Zoom Event - Not Recorded