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.
Marie Deneux, Senior Director Regulatory Science, Drugs and Biologics; Pauline Messina, Regulatory Scientist; Voisin Consulting Life Sciences.
July/August 2016 – Regulatory Rapporteur-TOPRA
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publication by
Marie Deneux
Senior Director Regulatory Science Drugs & Biologics
Marie assists international clients in the design and implementation of global product development plans and associated regulatory strategy, in particular in the area of rare diseases. She is involved in the development of biotech products, new chemical entities, cell and gene therapy medicinal products and repurposed drugs.
Pauline Messina
Regulatory Scientist Drugs and Biologics
Pauline is involved in different regulatory projects, conducting research and scientific writing in the framework of the design and implementation of Regulatory Strategies for the development of drugs and biologics. She also participates to lifecycle management and Marketing Authorization Application activities, including the setting of regulatory strategy, preparation of variation application dossiers, and review of product information.
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