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





