IDMP Standalone Agnostic Approach: Challenges and Achievements

Developing generic IDMP capabilities independently from the RIM system has gained increasing interest, similar to how eCTD publishing is handled separately from eDMS.

The expected benefits of this approach include the ability to adapt more quickly and efficiently to evolving regulatory guidance and requirements, without disrupting ongoing regulatory affairs (RA) activities, either in terms of systems or resources.

This presentation will explore the main challenges of this strategy, in particular:

  • How to optimize RIM–IDMP integration through automation,
  • How to minimize IDMP enrichment that is not reflected in source systems (such as RIM),
  • How to manage inconsistencies across RIM systems, IDMP systems, and PMS.

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