Workshop on advancing proof-of-concept data in paediatric oncology drug development

EMA is organising a workshop to receive a multi-stakeholder perspective on the generation and use of adequate proof-of-concept data in paediatric oncology.

• Date:
  Monday, 21 September 2026 , 13:00 - 16:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

This initiative is part of the Consolidated 3-year rolling workplan of the non-clinical domain for 2026-2028.

The workshop provides a platform for discussion to help inform the development of a future reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients.

The aims of the workshop are:

• to present the outcomes following the public consultation on the concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients;
• to gather stakeholder feedback on key questions, data needs, and perceived challenges to practical application, with a view to further strengthening the evidence-base supporting paediatric oncology development;
• to leverage learnings from oncology and discuss challenges in mechanism-of-action based paediatric developments beyond oncology, and what is needed to support such developments as foreseen under the new EU Pharmaceutical Legislation across other therapeutic areas. 

Registration

Participants can register for online participation, and submit questions until 18 September via EU Survey