Ksb D15 K0002

CPA Pathway

• CPA-05, CPA-07

Regulatory References

• ICH-E2D Sec 3.2
• MULTI-LIT-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L5 proficiency in regulatory information architecture
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (ICH-E2D Sec 3.2, MULTI-LIT-001)
4. Connect to related EPAs: EPA-02, EPA-04

Key Competencies

• Mastery of global regulatory databases including FDA FAERS, EudraVigilance, WHO VigiBase, and national regulatory repositories, understanding data structure, access limitations, reporting requirements, and temporal factors that influence data interpretation and utility for safety assessment.

Assessment Criteria

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

Related Skills

• Other D15 skills in Traditional Information Sources and Management
• Cross-domain integrations per DAG architecture

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