Third industry stakeholder platform on research and development support
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Date
- piatok, 18 máj 2018, All day
Miesto
- European Medicines Agency, Amsterdam, the Netherlands
This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, 'histology-independent indications' in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine development programmes, co-development with companion diagnostics and cross-decision maker collaboration in the space of horizon scanning activities. It also provides an opportunity for updates on post-authorisation evidence generation activities, paediatric medicines and the PRIME scheme.