CRED Practical Document Writing and Management
What happens next…delivery.xml
Not just eCTD submissions: - ASMF PMF PSUR Repository Paediatric Signal detection VNeeS
Related sequence is always the first sequence in the regulatory activity for Human submissions. Helps agency
Identify whether a Risk Management Plan is included for: • MAA • Variation Type IB / II • Extension • PAM • Renewal
Can you spot the mistake here?
New button Variations for H&V: Type IA, Type IAIN, Type IB, Type II, Transfer MA, Notification 61-3 (H only)
PO should be filled out for invoicing purposes
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