Third industry stakeholder platform on research and development support

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Date

Viernes, 18 Mayo 2018, Todo el día

Lugar

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.

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