Module232025

5/7/2025

Paediatric Clinical Trial Considerations – A regulatory perspective

Dr Angeliki Siapkara Senior regulatory affairs director – Paediatric oncology development team AstraZeneca

The Organisation for Professionals in Regulatory Affairs

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Agenda

1. Background: Why do we do paediatric drug development ? 2. Moving into Paediatric clinical trials • Paediatric formulations

• Dose selection and optimisation • Paediatric clinical trials challenges • Safety 3. Extrapolation 4. Developing global Paediatric Strategy : The Benefits of integrated paediatric drug development

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May 2025

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