Module 12 Presentations

RIMS in the System landscape (example)

xEVMPD

EMA SPOR

EC Union Register of medicinal products for human use

EMA

PV

Source

LIMS

CC QualityDocs

Internal systems

RIMS

ERP

SmPC eAF

Serialization

Dossier

External CMOs

Other external sources

Distribution partners

The Organisation for Professionals in Regulatory Affairs