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Preparing a Drug Registration for the US and the EU: Parallel or sequential applications? – Part 1

Published on: Feb 2, 2015

An overview of the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

Nathalie Boeglin, Alice Rolland, Frederic Pailloux and David Uguen.

February 2015 – Regulatory Rapporteur

Click here for Part 2

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