Module 12 Presentations

Latest EMA ePI developments

EMA developing and delivering ePI in line with their Agile methodology.

Nov First ePIs published on EMA´s PLM website

EMA action plan to improve Patient Information

Public consultation on ePI common standard

2022

2023

2017

Future ePI API and PMS integration

Ongoing ePI pilot: 21 companies 3 Centralised 2 MRP/DCP 6 National

Q3

Implementati on of Quarterly

system demo´s

The Organisation for Professionals in Regulatory Affairs