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 cover:

  • 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.

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