Talk Clinical Trials Innovation track
S0105 - Paediatric Clinical Trials: Challenges and Opportunities
Thu, Mar 20, 2025 · 10:30–11:40 AM CET Boston 1-2 Room, Congress Center Basel
About this session
This session is to exchange perspectives between stakeholders and regulators on the way forward with drug development programs and optimizing treatment programs for the pediatric populations. Methodologies and innovation on establishing safe starting doses in the pediatric population will be discussed. Special attention is given to clinical trials with neonates for which drug development is generally lagging behind. The interaction between Pediatric Investigational Plans, the respective pediatric clinical trials and the interpretation of regulatory framework (article 32 CTR) to optimize drug development for the pediatric population is discussed. Initiatives on how to foster pediatric clinical trials in EU are presented. Finally, the challenges on providing lay summary results for pediatric population targeting the specific trial population are discussed and examples presented.
Programme:
- 2. Human Starting Dose Considerations in Advanced Therapies and Pediatric Development Programs — Jan Willem Van der Laan
- Panel Discussion — Charles Benson
- 1. Drug Development in Neonates, Where Are We? — Solange CORRIOL-ROHOU
- 4. Producing an EU Pediatric Plain Language Trial Summary: A New Norm? — Laurence Van Bree
- 3. Fostering Pediatric Trials Under the CTR — Marianne Lunzer
Speakers
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Vice President Exploratory Medicine and Pharmacology · Eli Lilly and Company
Panelist
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Senior Assessor Pharmacology and Toxicology · MEB
Speaker
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Sr Regulatory Affairs & Global Policy Director · EFPIA - SCR Consulting
Speaker
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Professor of Clinical Pharmacology, Pediatric Intensivist · Radboud University Medical Center
Chair
