Eleventh industry stakeholder platform on research and development support
Event
Human
Research and development
Date
- Monday, 4 December 2023, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
Event summary
This is the eleventh 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 related to development support activities, such as scientific advice and qualification, as well as specifics for paediatric and orphan medicines.
This meeting includes information on:
- Latest updates concerning the development support offering for programme-specific evidence planning,
- The action plan following the multi-stakeholder workshop on qualification of novel methodologies,
- Progress with the agility in paediatric processes,
- Evidence planning for combination developments comprising of medicinal products with medical devices and/or companion diagnostics,
- The revamped Business Pipeline meetings,
- Recent and upcoming developments of the IRIS platform for R&D processes,
- Industry will provide perspectives on future-proofing the regulatory system as well as their preparation for the future activities at the regulatory / HTA interface.