Ksb D10 K0041

• EPA-03:3006-3008
• EPA-05:3011-3012
• EPA-08:3018-3019

CPA Pathway

• CPA-02, CPA-03

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in ai risk classification frameworks
2. Apply evaluate level cognitive skills to evaluate the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-03, EPA-05, EPA-08

Key Competencies

• Comprehensive understanding of AI risk classification frameworks applicable to pharmacovigilance including CIOMS WG XIV risk-based approach, EU AI Act high-risk classification criteria, FDA risk-based validation expectations, and organizational risk assessment methodologies. Knowledge of factors determining AI risk level: safety impact, autonomy level, reversibility of decisions, and affected population characteristics.

Assessment Criteria

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

Related Skills

• Other D10 skills in Risk-based AI Implementation
• Cross-domain integrations per DAG architecture

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