Module 1 2021

30/06/2021

EU Regulatory Procedures Strategic Choices

Connie van Oers – Global RA-CMC Biologics Sanofi Genzyme

The views expressed in this presentation are solely the view of the presenter and do not necessarily reflect the views of Sanofi

The Organisation for Professionals in Regulatory Affairs

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This presentation covers

 Overview of Authorities involved in Marketing Authorisations in the EU  Legal Basis of EU Marketing Authorisations  Overview of EU Regulatory Procedures  Basics of Mutual Recognition/Decentralised/Centralised Procedure  Strategic Factors that may influence the choice of Procedures  Options within the Procedures

The Organisation for Professionals in Regulatory Affairs

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