Ksb D01 K0054

CPA Pathway

• CPA-01

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L3 proficiency in ai ethics in drug safety
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

• Comprehension of ethical considerations in AI-enabled pharmacovigilance including algorithmic transparency, patient data privacy in AI training, equitable AI access across regions, and responsible AI development principles. Understanding of CIOMS, FDA, and EMA ethical frameworks for AI in healthcare.

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 Transformation of PV
• Cross-domain integrations per DAG architecture

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