Module 12 2019

Current status of ongoing programmes: CESP & SPOR

Data being created by Industry (by using SPOR data), reviewed by Regulator and flowing directly into SPOR

CESP

Dossier

CESP

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 Organisation for Professionals in Regulatory Affairs