15th industry stakeholder platform on research and development support
EventHumanResearch and development
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- The original event time is:
- четвъртък, December 4, 2025 - 12:30 - 17:30 Amsterdam time (CET)
Date
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Местоположение
- European Medicines Agency, Amsterdam, the Netherlands
Event summary
This is the fifteenth 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:
- strengthening the delivery of scientific advice to efficiently support development programmes including agile scientific advice and broad scientific advice affecting multiple products
- modernising the Qualification of Novel Methodologies framework
- translating the experience from the piloting of the new PRIME features into optimised operations
- feedback from the HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment
- proposal for the pilot of a voluntary data submission framework to establish potential alternatives to animal testing in line with the 3Rs principles
- progressing the support to paediatric developments
- identification of product-specific bioequivalence guidelines
- gocus group to explore opportunities for the use of Real-World Data (RWD) and the generation of Real-World Evidence (RWE)
- strengthening support to evidence generation for combination (MD/IVD) Products