Ksb D11 K0044

• CPA-03

Regulatory References

• FDA-STAT-002
• EMA-GVP-002
• EMA-GVP-012
• UK-MHRA-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in healthcare system transformation
2. Apply create level cognitive skills to create the topic
3. Reference relevant regulatory guidance (FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009)
4. Connect to related EPAs: EPA-07, EPA-08, EPA-16

Key Competencies

• System redesign principles, change management, capability building, sustainability planning, scale-up methodology

Assessment Criteria

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

Related Skills

• Other D11 skills in Policy Integration and Healthcare Economics
• Cross-domain integrations per DAG architecture

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