Ksb D01 K0053

• EPA-01:3001-3003
• EPA-10:3023-3024

CPA Pathway

• CPA-01

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L2 proficiency in ai impact on pv landscape
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-01, EPA-10

Key Competencies

• Understanding of how artificial intelligence is transforming pharmacovigilance practice including automation of routine tasks, enhancement of signal detection capabilities, augmentation of human decision-making, and evolution of regulatory expectations. Knowledge of AI adoption curves in pharmaceutical industry and implications for workforce development.

Assessment Criteria

• Can explain 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