Module 12 Presentations

EMA publications of interest

European Medicines Regulatory Network Strategies

SPOR operational planning

Portfolio Roadmap

Translates into multi-year roadmaps that shows EMA’s business and IT capability development priorities per value stream SPOR increasingly being connected in the different value streams, projects and systems

Translates into shorter-term operational planning per SPOR domain One plan per SPOR domain shared in SPOR webinars 2x a year. Shows per domain how it is (to-be) used across the EMA’s value streams. Often includes direct impact and actions for industry to undertake e.g., review and update cleansed development substance in xEVMPD

Multi-year strategies that provide long-term direction for business areas

SPOR recognised to play key role in realising these strategies

Direct impact for RA

A regulatory professional will have mostly short-term practical impact from changes communicated in SPOR operational plannings. However, the Portfolio Roadmap makes clear the longer-term direction and (future) connections across EMA’s value streams and systems which are valuable for consideration in data and technology strategic planning

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12