CRED 8 Presentations

01/07/2024

CRED Navigating European Regulatory Procedures

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CRED Navigating European Regulatory Procedures 11-12 July 2024 Key EU regional considerations

Eesha Vyas, Oncology Regulatory Lead, GSK

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.

• 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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