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EMA – Twelfth meeting of the industry stakeholder platform on research and development support 4 July 2024: event materials are now  available

This meeting, held the 4 July 2024, was the twelfth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addressed 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:

  • development support offering for programme-specific evidence planning, including provision of scientific advice on paediatric developments and piloting of scientific advice on clinical trial design;
  • the implementation of the new fee regulation;
  • completion of onboarding of R&D processes onto the IRIS platform;
  • EMA survey focusing on early engagement meetings that foster innovation;
  • evidence planning for combination developments comprising of medicinal products with medical devices and/or companion diagnostics;
  • action plan to future-proofing the qualification of novel methodologies platform.

Key updates included the introduction of consolidated advice for clinical trials, enhanced scientific support for paediatric development, and updates on the new Fee Regulation set to take effect in 2025. Additionally, a proposal for a focus group on using real-world data for regulatory decisions was discussed.

Find the presentation materials and the Highlight report of the event on the EMA Website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (21 octobre 2024). EMA – Twelfth meeting of the industry stakeholder platform on research and development support 4 July 2024: event materials are now  available. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/12jhh


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