This virtual event, organised by the European Medicines Agency (EMA), aims to encourage early and efficient interactions with the regulators by highlighting pre-marketing support in medicine development in rare diseases.
The meeting will highlight and explain existing tools in the context of early product development strategy. These include:
- orphan designation
- protocol assistance
- the PRIority MEdicines (PRIME) scheme.
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 European reference networks (ERNs), who are often at the forefront of medicine development in rare and neglected diseases.