CRED ERP 25

01/07/2025

CRED Navigating European Regulatory Procedures

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CRED Navigating European Regulatory Procedures 8-9 July 2025 Key EU regional considerations

Ian Thomson, EMEA Regulatory Affairs Leader, Johnson & Johnson

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

• To gain a good understanding of EU regional requirements for the regulatory dossier

• To be aware of some key considerations when preparing eCTD module 1 components for the EMA centralised and Reference Member State (RMS) for MRP (Mutual Recognition Procedure)/DCP (Decentralised Procedure).

The Organisation for Professionals in Regulatory Affairs

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