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
1
The Organisation for Professionals in Regulatory Affairs
1
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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2
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