Module 12 Presentations

EMA’s goal: a Target Operating Model (TOM)

TOM is a business process model to ensure data quality and consistency and to optimise the exchange of application data between regulators and applicants.

➢

Minimize Administrative burden

✓ Re-use the same data for regulatory activities and centralised databases (such as PMS)

✓ Abandon separate Article 57/xEVMPD (post-approval) data feeds

✓ Improve electronic data exchange in the network (CTIS, national databases, etc.)

➢

Integrate SPOR

➢ Ensure that centralised and NCA/EMA databases have consistent data

The Organisation for Professionals in Regulatory Affairs