Development of orphan products and the impact of the EU Paediatric Regulation, TOPRA Vol 9, No.10

Published on: Oct 15, 2012

Development of orphan medicinal products (OMPs) is challenging by nature: knowledge is usually limited; the patient population are small and often frail; and the implementation of the Paediatric Regulation in the EU has added a layer of complexity, especially for OMPs.

Marie Deneux, Séverine Marconi, David Uguen

2012 – Regulatory Rapporteur

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Development of orphan products and the impact of the EU Paediatric Regulation, TOPRA Vol 9, No.10

Published on: Oct 15, 2012

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