Orphan medicines development in Europe and Japan
EventCorporateRare diseases
Date
- Thursday, 19 September 2013, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
The EMA Orphan Medicines Section held a workshop specifically tailored for Japanese Pharmaceutical Industry, which have a European Regional Office in London, UK.In this workshop the EMA presented different aspects of the orphan medicinal designation process and programmes associated with it. The programme was specifically divided up into the orphan designation process proper, the incentives and their relation to small to medium enterprises and finally the post-designation incentives and regulatory considerations. Under this last topic specific issues associated with protocol assistance, paediatric investigational plan and aspects associated with the centralised procedure were highlighted.