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Session 5, Track B: Advancing Pediatric Clinical Trials: Innovation, Regulation, and Operational Excellence
Session Chair(s)
Katalin Bertenyi, MSc
Manager, Centre for Blood, Blood Products and Biotherapeutics, Health Canada, Canada
Foo-Lim Yeh
Allergan Aesthetics, Neuroscience, and Specialty Head, Regulatory Affairs, AbbVie, Canada
This session will provide an overview of current perspectives on pediatric clinical trials, with emphasis on the regulatory, operational, and scientific considerations that shape study design and delivery. It will bring together perspectives on pediatric platform trial design, an update on Health Canada’s Pediatric Drug Action Plan and its relevance to ongoing pediatric drug development efforts, and practical challenges and opportunities across the pediatric trial landscape. The overall goal is to share strategies that can make pediatric trials more efficient, feasible, and better aligned with practical study execution.
Learning Objective : At the conclusion of this session, participants should be able to: - Summarize the role of pediatric platform trials and other study approaches in advancing pediatric drug development
- Identify common barriers to pediatric trial execution and strategies to address them
- Explain the relevance of Health Canada’s Pediatric Drug Action Plan to ongoing pediatric development efforts
Speaker(s)
Elisa Koppelman, MPH
Team & Program Director, MRCT Center, United States
Pediatric Platform Trials: Speeding the Delivery of Safe and Effective Medicines to Children