The Committee for Orphan Medicinal Product (COMP) of the European Medicines Agency (EMA) will organise a Workshop on support for orphan medicines development on 30 November 2020. The virtual event aims to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases. Existing tools such as orphan designation, protocol assistance and PRIME scheme will be highlighted and explained in the context of early product development strategy.
Stakeholders have an opportunity to express their views in relation to early medicine development and regulatory interactions.
The workshop is targeted at small to medium enterprise medicine developers, academia, patients, healthcare professionals and ERNs who are often at the forefront of medicine development in rare and neglected diseases.
Further information about the agenda and registration is available here.