PublicationPaediatric

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

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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publication by

Marie Deneux

Senior Director Regulatory Science Drugs & Biologics

Séverine Marconi

Senior Regulatory Scientist

David Uguen

Executive Director Drugs and Biologics

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

Download the full publication now

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

Download the full publication now

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