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

Download the full publication now

Fill in the form to download the content

*I have read and agreed to the Terms of Use and the Privacy Policy.Yes, I would like to receive communications regarding VCLS services and events

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

publication by

Accelerating Innovation: FDA Expedited Programs 101

Achieve Success for Your First US Product Application – Pathway to IND

A deep dive into the regulatory framework for Phage Medicinal Products

Sponsors of Clinical Trials in the EU/EEA – Call for Action!

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

Download the full publication now

publication by

More resources

Accelerating Innovation: FDA Expedited Programs 101

Achieve Success for Your First US Product Application – Pathway to IND

A deep dive into the regulatory framework for Phage Medicinal Products

Sponsors of Clinical Trials in the EU/EEA – Call for Action!