Module 12 2019

Regulatory compliance: Process improvement: RMS & OMS data entered once and available across Pharmacovigilance and MA process SPOR High-level Timelines ISO IDMP (11239 & 11240) compliant Referential data services Organisation dictionary: List of organisations with associated physical locations to support EU-wide regulatory activities

2016

2017

2018-2019

20xx

Publication of EU IGs to support PMS & SMS

PMS & SMS phase 1 external go-live

RMS internal EMA release 1 live

RMS & OMS external go-live

OMS internal EMA release 1 live

PMS & SMS integration with xEVMPD

PMS & SMS phase 1 re- started, S&P subgroup

RMS & OMS integration with xEVMPD

Integration with CESSP MAA

OMS integration with eAF

meetings resumed

The Organisation for Professionals in Regulatory Affairs