Module 12 Presentations

PLM eAF Data Flow

SIAMED

Internal trigger

PLM eAF

Notification to RA of a change requiring submission

xEVMPD Submission

Submission package

Validation

FHIR

FHIR

Assessment

Dossier

Approval

SMS

OMS

RMS

PMS

Alignment of SPOR data in M1 5 dossier compilation

Continuous process to align company data to SPOR

SMS OMS

PMS

RMS

The Organisation for Professionals in Regulatory Affairs