Module232025

12/05/2025

Optimising Drug Development through Effective Paediatric Strategies

TOPRA Master Class, 14 May 2025, London, UK Dr Martine Dehlinger-Kremer Vice-President, Scientific Affairs, Paediatric SME, ICON, Plc Chair of Paediatric WG and President, EUCROF

The Organisation for Professionals in Regulatory Affairs

1

1

Optimising Drug Development through Effective Paediatric Strategies

Why Paediatric Clinical Development?

•

Global Regulatory Landscape

•

• Current Situation for Paediatric Research – Challenges and Possible Solution

• Early Integration of Paediatric Considerations - Clinical and operational considerations - Tool for inclusion of adolescents in adult trials - The FAIR Initiative - Overview of Clinical Trials Involving Adults and Adolescents

• Insights and Outcomes from Combined Adolescent-Adult Clinical Trials - Experience with Combined Adolescents / Adults Clinical Trials - Outcome of combined paediatric and adult trials

Summary and Conclusion

•

The Organisation for Professionals in Regulatory Affairs

2

M Dehlinger-Kremer, 14 May 2025

2