CRED 8 Presentations

01/07/2024

Content Validation

From submission deadline to procedure start date • “Regulatory and administrative” content validation occurs after the technical validation (sometimes can feel like a pseudo-assessment) • Validation occurs before the scientific evaluation of the dossier • Ensure your team are on standby to address any validation issues • Validation Supplementary Information (VSI) sent if any deficiencies • Issues must be addressed by procedure start date via a new eCTD sequence • Maximum of 2 months permitted from VSI to satisfactorily resolve issues • If issues not resolved, negative validation outcome is provided • Applicant must resubmit (pay administrative fees)

The Organisation for Professionals in Regulatory Affairs

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After Validation Confirmed…relax (briefly!!!)

The Organisation for Professionals in Regulatory Affairs

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