Module 12 Presentations

SPOR usage in Regulatory Activities

Investigational (Pre-submission)

Authorisation (Submission)

Post-authorisation

Product

lifecycle

Pharmacovigilance (as-is via eSubmissionGateway & web client; to-be - tbc) • PSUR • ICSR • Maintenance of Art 57

ePI

Marketing Authorisation Applications (via PLM-eAF) • CP; • DCP; • MRP; • National; •

Clinical Trials Applications (via CTIS)

Shortages

Post-authorisation Applications & Referrals (as-is via eAF; to-be via CESSP)

DARWIN EU

And more in future .

Future EU initiatives that will depend on SPOR data

Inspections (via Eudra GMDP integrated with SPOR)

Use cases i.e. Regulatory activity dependent on SPOR data

Master Data Management ( Substance, Product, Organisation, Referentials)

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12