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Session 4: Manage Substantial and Non-Substantial Modifications
Session Chair(s)
Fatima Pimentel
Director, Regulatory Consulting
Syneos Health, Spain
This session covers subsequent change to the application dossier for certain business cases including implications on required dossier information and components
Topics covered:
- - Non-substantial modification dossier update submissions
- Substantial modification applications (general principles, requests for trial status extensions, change of main sponsor)