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EMA – Publication of the event’s materials of the Thirteenth meeting of the industry stakeholder platform on research and development support held the 2 December 2024

This was the thirteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related to development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines.

This meeting focused on:

  • recent developments to optimise support for programme-specific evidence planning;
  • specifics of Scientific Advice for paediatric developments;
  • initial work of the Focus group to explore opportunities for the use of Real World Data (RWD) and the generation of Real World Evidence (RWE);
  • updates on processing Scientific Advice requests regarding New Fee Regulation;
  • onboarding of paediatric procedures onto IRIS;
  • discussion on experience with Portfolio and Technology meetings (PTMs).

The event’s materials are now available on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (4 février 2025). EMA – Publication of the event’s materials of the Thirteenth meeting of the industry stakeholder platform on research and development support held the 2 December 2024. ELSIBI. Consulté le 18 février 2026 à l’adresse https://doi.org/10.58079/138p4


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