Module 12 Presentations

RIM System Capabilities overview

• Submission forecasting & Resource planning • Dossier management • Submission management: assemble publish QC • Product registration management • Health Authority commitments and interactions • Archiving • Labeling Management (content & compliance) • Reporting, Dashboards, Analytics • Data Standards & Data Governance • Regulatory intelligence • Ad / promotions

Product Change Control to ensure alignment with

Supply Chain Clinical Pharmacovigilance Product Release Labeling / Artwork Vendors Manufacturing Etc.

The Organisation for Professionals in Regulatory Affairs