CRED 8 Presentations

01/07/2024

SCHEDULING THE SUBMISSION

The Organisation for Professionals in Regulatory Affairs

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Scheduling your submission (1)

• Availability of rate-limiting data • CSRs • Pivotal Stability (12m for NCE) • Carcinogenicity report etc. • Agreed PIP – Compliance required in advance of submission – 3m

• Local regulatory requirements • Number of patients exposed (safety) • Long-term data (tox and clinical) Negotiate with Agency • What can you provide post filing? • Build in time for pre-submission meetings/impact of Agency & internal teams’ holidays •

The Organisation for Professionals in Regulatory Affairs

4