Module 12 Presentations

As a Regulatory Professional, what should I keep an eye on? Below initiatives are the most important to keep an eye out for. However, it does depend on your and your company’s products, services, and role.

PLM eAF will be the to-be portal to generate your submission-eAF supported by data. Developments here may impact the need on data for your future submissions as well as on other domains such as: technology, processes, and roles and responsibilities. The IRIS platform is relevant for applications and advice from EMA and its use may only increase in the future. Moving from eCTD 3.2 to 4.0 will be a big change. Keep an eye on timelines and pilot(s) (results) to anticipate on your organisation’s needs. ePI is moving fast, make sure to keep up to date on developments to understand what is required from your organisation on this topic. Different HAs incl. FDA, Swissmedic, MHRA have approaches for IDMP implementation. Collaboration via the GIDWG will be important for harmonisation

01 02

PLM eAF

EMA SPOR (IDMP and PMS, incl. ESMP)

03

IRIS Platform

04

eCTD 4.0

05

ePI

0 06 Global IDMP

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12