Ksb D12 K0048

• EPA-06:3013-3015
• EPA-09:3020-3022
• EPA-16:3035-3036

CPA Pathway

• CPA-04

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in eu ai act pharmacovigilance implications
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Mastery of EU AI Act requirements applicable to pharmacovigilance including risk classification categories for AI systems, conformity assessment obligations, transparency requirements for automated decision-making, and post-market monitoring expectations. Understanding of high-risk AI system designation criteria relevant to drug safety, documentation requirements under Annex IV, and EMA preparations for AI Act implementation in medicines regulation.

Assessment Criteria

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

Related Skills

• Other D12 skills in EU AI Act Compliance
• Cross-domain integrations per DAG architecture

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