Date
- Monday, 30 November 2020
Location
- OnlineEuropean Medicines Agency, Amsterdam, the Netherlands
Event summary
This virtual event 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:
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.
Documents
Report - Workshop on support for orphan medicines development
Agenda - Workshop on support for orphan medicines development
Presentation - Workshop on support for orphan medicines development: Academic perspective (Juan A. Bueren)
Presentation - Workshop on support for orphan medicines development: EMA support to SMEs and academia (Hélène Casaert)
Presentation - Workshop on support for orphan medicines development: EMA supporting the orphan medicinal product development (Andrea Braun-Scherhag)
Presentation - Workshop on support for orphan medicines development: European joint programme on rare diseases (Daria Julkowska)
Presentation - Workshop on support for orphan medicines development: International rare diseases research consortium (IRDiRC) drug development guidebook (Virginie Hivert)
Presentation - Workshop on support for orphan medicines development: Orphan designation and orphan medicines in the EU (Frauke Naumann-Winter, Darius Matusevicius)
Presentation - Workshop on support for orphan medicines development: Protocol assistance, PRIME and parallel distribution (Armando Magrelli)
Presentation - Workshop on support for orphan medicines development: The patients’ perspective on the value of orphan designation (Nicolas Sireau)