A non-profit stakeholder developing or gathering evidence, including the use of scientific advice as the main regulatory tool, for the repurposing of a medicinal product that can be e.g. a patient organisation, academia, collaborative groups or European Reference Networks (ERNs)’. A champion is typically :
- Able to coordinate and/or foster the research programme up until the point of full engagement by a pharmaceutical company.
- Initially responsible for liaising and leading the interactions with regulatory authorities and pharmaceutical companies/other stakeholders.
- Transparent regarding interactions with relevant pharmaceutical company(ies) in charge of filing the initial request for scientific/regulatory advice on the basis of the available data.