Ksb D07 K0003

• CPA-02, CPA-05

Regulatory References

• FDA-CFR-002
• ICH-E2C(R2)
• ICH-E2F
• EMA-GVP-004

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in regional system variations
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• FDA FAERS, EudraVigilance, Japanese JADER, Health Canada Canada Vigilance, PMDA JFDA variations

Assessment Criteria

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

Related Skills

• Other D07 skills in International Reporting Framework Integration
• Cross-domain integrations per DAG architecture

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