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.


Concept Paper 


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