Module 12 Presentations

eAF move document to data

• eAF PDF → CESSP → DADI → PLM

CESP

Dossier

CESSP / DADI / PLM

EMA/ NCA

EMA Gateway

Import file for IT systems

Draft Cover Letter,

SPOR

Draft a business and technical scenario how PMS could consume and utilise application data

Start and Finalise Application Dataset

Finalise dossier submission

Process submission

Submit

The Organisationfor Professionals in Regulatory Affairs

Slide 78