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Session 3: Manage Submitted Application Under Evaluation
Session Chair(s)
Fatima Pimentel
Director, Regulatory Consulting
Syneos Health, Spain
This session provides practical guidance how to manage applications under evaluation and options how to RFI responses and discuss options to withdraw or resubmit an application
Topics covered:
- Response to RFI
- Application dossier change as part of an RFI response
- Withdrawal an application
- Resubmission of initial application
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