ksb-d07-k0003

name: "KSB-D07-K0003" description: "Regional System Variations: FDA FAERS, EudraVigilance, Japanese JADER, Health Canada Canada Vigilance, PMDA JFDA variations..." version: "1.0.0" domain: "D07" domain_name: "Spontaneous Reporting Systems" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain regional system variations" - "what is regional system variations" - "explain regional system variations" epa_mapping: "EPA-02, EPA-04, EPA-05" cpa_mapping: "CPA-02, CPA-05" regulatory_refs: "FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004"

KSB-D07-K0003: Regional System Variations

Overview

Domain: D07 - Spontaneous Reporting Systems Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

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

Context

• Major Section: Global Spontaneous Reporting System Architecture
• Section: International Reporting Framework Integration

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• 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