Module 12 Presentations

Example Use Case 1: Using RIMS data to submit Registration information - as data

• Regulatory information required for submission is generated from RIMS Examples: • Cover letter • Application form • Annexes to Application Form • eCTD envelope

• Gateway delivery file • Module 3 information

Regulatory approval

M3

authority review

eAF

• Regulator can import data into their systems

• Exchange of information automated in future • Validation • List of Questions • Approval

CTD documents

eCTD submission

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A pproved CC

RIMS

structured data file

structured authoring

The Organisation for Professionals in Regulatory Affairs