Twelfth meeting of the industry stakeholder platform on research and development support
EventHumanResearch and development
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Date
- Πέμπτη, 4 Ιούλιος 2024, Ολοήμερο
Τόπος
- European Medicines Agency, Amsterdam, the Netherlands
Event summary
This is the twelfth 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 focuses 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.