Module 12 Presentations

Use cases using standardised medicinal product data

• Management of substance information • Product acquisition capability using data set • Reporting optimization across divisions & systems • S,O, and R pre-registration using data

Cross Functional

• Process of CCDS – SmPC/ SPL. Authoring and comparison

Label

• E2E change control using data • Compare registrations across regions using common data standards

Quality

• Populate electronic regulator forms • CMC structured content authoring and supporting PQ – CMC submissions

Regulatory

• CTIS and IND support using IMP common data • Real-time dynamic dossier development using common metadata (IDMP)

Clinical

Supply Chain/ Manufacturi ng

• Batch release optimization • Serialization process

• Increase efficiency of recalls using data • Optimization of shortage management

• Pharmacovigilance: Improved signal detection, PSUR/ PSMF preparation

PV

The Organisation for Professionals in Regulatory Affairs