EMA IDMP Roadmap: Updates, Requirements and Impact on Industry (Session 1 of 2)
By the end of 2024, EMA released updated IDMP guidance and the PMS implementation guide, following key milestones including the go-live of PMS. Closely connected to SPOR, XEVMPD, SIAMED, and various EMA platforms, the IDMP project demands active collaboration between industry and NCAs.
In this session, we covered:
- Key updates to PMS and their impact on industry
- EMA guidance updates and compliance prerequisites
- Use of the Union List of Critical Medicines and the ESMP platform
- PMS as a central source of product data
- Revised IDMP timelines and required industry actions
- MAH obligations and practical implementation challenges
The EMA IDMP project remains active, with increasing complexity. Achieving compliance requires data readiness and process optimisation to meet evolving deadlines and implementation phases.
Ennov & MAIN5 Webinar on Wednesday, June 18
EMA IDMP Roadmap: PMS Data Alignment (Session 2 of 2)
Join us for the second session in our IDMP webinar series, presented by Ennov & MAIN5, focusing on the practical realities of PMS data reconciliation as EMA’s migration rules continue to evolve. With many MAHs learning that initial alignment is just the start, this session explores the shift toward ongoing PMS data comparison and enrichment.
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