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SPOR
xEVMPD
Federated Data
Stewardship
Systems Integration

SPOR and xEVMPD: Centralize What Matters, Federate the Rest

Smart SPOR strategy

The EMA’s SPOR initiative and xEVMPD requirements force harmonized master data. Going fully centralized slows markets; letting every affiliate do its own thing creates chaos.

Assyro Team
2 min read

SPOR and xEVMPD: Centralize What Matters, Federate the Rest

The EMA’s SPOR initiative and xEVMPD requirements force harmonized master data.

Going fully centralized slows markets; letting every affiliate do its own thing

creates chaos.

This playbook strikes the balance. We will define a federated model, appoint data

stewards, and integrate systems so core data stays consistent while local teams

remain agile.

Why it matters

Clean master data underpins submissions, variations, and IDMP reporting. When

fields are misaligned, labels contradict, health authority questions spike, and

market entries slip.

The playbook

Federated model
  • Decide which attributes are global (identifiers, reference data) and which are

local (country-specific labelling, reimbursement codes).

  • Document handoffs and change processes between central and local teams.
  • Revisit quarterly to capture regulatory or business changes.
Data stewards
  • Assign stewards for each domain and region with SLAs, KPIs, and escalation

rights.

  • Provide dashboards showing completeness, accuracy, and timeliness.
  • Run monthly steward forums to resolve cross-market conflicts.
Integrations
  • Connect RIMS, ERP, labelling, and PV systems using APIs or managed feeds.
  • Validate data transformations, monitor integration health, and reconcile

variances.

  • Trigger alerts when data changes without authorization.

Q&A highlights

  • What centralize? Core identifiers and reference data.
  • What federate? Country-specific attributes.
  • How to keep on track? Governance council with shared dashboards and action logs.

Metrics and signals

Monitor completeness/accuracy scores, number of data issues raised by affiliates,

turnaround time for data changes, and regulatory queries linked to master data.

30-day action plan

  • Inventory current data owners and identify overlaps.
  • Draft the initial federated model and validate it with EU, global, and market

teams.

  • Launch the steward forum and publish baseline data quality metrics.

Common pitfalls to avoid

  • Centralizing everything in the name of control, leaving regions stuck.
  • Assigning stewards without authority or tools.
  • Ignoring integration monitoring until errors pile up.

Sustain the win

Review steward performance monthly, refresh models after regulatory updates, and

rotate council leadership. Highlight wins where accurate data accelerated

submissions to reinforce adoption.