Tenth industry stakeholder platform on research and development support
EventHuman
Dutch is available via eTranslation, the European Commission's machine translation service.
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Date
- dinsdag, 11 juli 2023, Hele dag
Locatie
- European Medicines Agency, Amsterdam, the Netherlands
Event summary
This is the tenth 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.
The meeting includes information on:
- progress with the implementation of the recommendations to further strengthen the PRIME scheme,
- progress with the implementation of initiatives to optimise the application of the PIP framework,
- cooperation at the HTA/regulatory interface,
- development of complex generics,
- update on latest developments in scientific advice along with reports from both the multi-stakeholder workshop on qualification of novel methodologies and from the Focus group to discuss opportunities for provision of scientific advice for medicinal product developments also comprising of devices and/or companion diagnostic.