Ksb D13 K0046

• EPA-18:3039-3040
• EPA-19:3041-3042

CPA Pathway

• CPA-06, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in ehds and darwin eu integration
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-18, EPA-19

Key Competencies

• Understanding of European Health Data Space (EHDS) framework and its integration with pharmacovigilance AI applications including data access mechanisms, interoperability standards, cross-border data sharing protocols, and secondary use provisions for safety research. Knowledge of DARWIN EU® real-world evidence platform capabilities, network analytics tools, and their application to AI-enhanced signal detection and benefit-risk assessment across EU member states.

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D13 skills in EU Data Infrastructure
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31