Ksb D13 K0047

• 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 L4 proficiency in cross-regulatory ai alignment
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

• Comprehensive understanding of international AI regulatory harmonization efforts including ICH AI-related initiatives, ICMRA collaboration on real-world evidence and AI, bilateral FDA-EMA AI discussions, and WHO global AI governance frameworks. Knowledge of convergence opportunities and divergence points between FDA AI guidance, EU AI Act, and other major regulatory approaches (PMDA, Health Canada, MHRA) for pharmacovigilance AI applications.

Assessment Criteria

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

Related Skills

• Other D13 skills in International Regulatory Coordination
• Cross-domain integrations per DAG architecture

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