July / August 2016
Regulatory Rapporteur - TOPRA

This article describes the regulatory frameworks and incentives associated with orphan drug designation (ODD) in the EU and the US, as well as capturing key strategic considerations needed to achieve successful orphan drug product development and registration in both regions.

Pauline Messina, Regulatory Scientist, Marie Deneux, Senior Director Regulatory Science, Drugs and Biologics; Voisin Consulting Life Sciences.

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