In light of IDMP implementation, EMA is delivering the SPOR data management services. However, the industry is facing a number of challenges in preparation for PMS. Particularly agreeing on a Target Operating Model on how data is going to be submitted, validated, assessed and approved.

In this workshop we discussed the key principles of the TOM and brainstormed on key milestones & deliverables, prioritization of activities within the network and a proposed road map. In addition, we discussed use cases of good quality regulatory data. What are the possibilities for automation and optimization of processes?

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