CRED 8 Presentations

08/07/2024

MRP/DCP - Practical Tips Pre-submission activities/Building a story Develop realistic timelines

● Understand deliverables from each functional areas ● Plan your pre-submission meeting (legal basis, dossier content…) and implement its feedback ● Tradename selection? ATC code? Pediatric Requirements? ● Confirmation of your RMS

Building your application “Tell me the story, and I will tell you if I agree” ● Presentation of clear, easy, consistent, synthetic dossier ● Proactive vs Reactive ● Preparation of a Table of Content and a Risk Register

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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MRP/DCP - Practical Tips Validation Phase

In theory, resolution within 14 days of submission ● Administrative check to ensure application is valid, complete and contains all appropriate documentation

In practice, can be a lot longer ● Between 6 to ~100 days depending on the issues

– Application not received/modules are missing – Proposed MAH not established in the EEA – Missing/incorrect fee ● Role of RMS pre-submission meeting + Discussion with RMS prior to submission to limit the impact

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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