Ksb D13 K0048

CPA Pathway

• CPA-06, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in international ai harmonization
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-18, EPA-19

Key Competencies

• Understanding of international coordination challenges for AI in pharmacovigilance including cross-border data sharing for AI training, regulatory recognition of AI validations, harmonized AI performance standards, and global AI governance frameworks.

Assessment Criteria

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

Related Skills

• Other D13 skills in Cross-Border AI Coordination
• Cross-domain integrations per DAG architecture

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