Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Michiel Stam, management consultant and regulatory lead at MAIN5, to explore what it really takes to prepare for EMA’s PMS data enrichment deadlines.
Closing the Data Gap for PMS Readiness
As the EMA’s Product Management Service (PMS) enrichment deadlines creep ever closer, companies are discovering just how far internal data often diverges from what’s been migrated from XEVMPD or SIAMED. Michiel and I unpack the practical realities: from data ownership and inconsistencies in SmPCs to the limits of manual reconciliation and the promise of automation.
What becomes clear is that PMS readiness isn’t a one-time project. It requires scalable, sustainable processes, strong data governance, and a cross-functional mindset—especially as IDMP maturity brings in data from supply chain, R&D, and manufacturing. This episode is all about turning regulatory compliance into enterprise value.
Michiel’s top resources:
- Take the first step to readiness. Download the IDMP Starter Pack
- Is your portfolio ready for enrichment? Access the downloadable PDF timeline
- Understand long-term alignment strategy. Watch the PMS Data Alignment webinar
Bonus:
- Want PMS-ready data without overhauling your RIM? Learn about Ennov EASI