8th Workshop, Barcelona: “Impact of the EU Paediatric Regulation on Orphan Drug Development”

8th Workshop of the Eurordis Round Table of Companies:

“Impact of the EU Paediatric Regulation on Orphan Drug Development”

 

June 20th, 2008

Barcelona, Spain

Fabrizia Bignami

One year after the adoption of the EU Paediatric Regulation, this workshop was an opportunity to learn how the regulatory professionals interpret and implement it in practice. In particular, how setting up a paediatric investigation plan links up with the various phases of orphan drug development (designation, protocol assistance, marketing authorisation). The afternoon discussion clarified the distinctive nature of the development of medicines for use in children and how to facilitate it.

Participants: 53

Key feature: first time that the orphan drug community analysed the benefits of the newly implemented paediatric regulation.

Programme 

Concept Paper 

Proceedings

For ERTC Members only, this document is password protected. If you want to become a member, find out more here or contact Anne-Mary Bodin, Operations Assistant.

 

 
 
A voz das pessoas com doenças raras na EuropaEURORDIS A voz internacional das pessoas com doenças raras, Rare Diseases InternacionalRare Disease International Reúne doentes, famílias e especialistas para partilhar experiências num fórum multilinguístico. RareConnect O programa Rare Barometer é uma iniciativa da EURORDIS para a realização de inquéritos para transformar a experiência das pessoas com doenças raras em números e factos que podem ser partilhados com os responsáveis pela tomada de decisões.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Adira ao maior encontro europeu das partes interessadas no âmbito das doenças raras na Conferência Bienal Europeia sobre Doenças Raras e Produtos Órfãos. A ECRD é uma iniciativa da EURORDISEuropean Conference on Rare Diseases