Ksb D01 K0055

CPA Pathway

• CPA-01

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in pv ai governance frameworks
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-01, EPA-10

Key Competencies

• Understanding of governance structures required for AI in pharmacovigilance including organizational accountability models, AI system inventory management, model risk management principles, and regulatory compliance frameworks for AI oversight in drug safety operations.

Assessment Criteria

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

Related Skills

• Other D01 skills in AI Governance Fundamentals
• Cross-domain integrations per DAG architecture

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