| name | KSB-D04-K0005 |
| description | Regional Variations: FDA (FAERS), EMA (EudraVigilance), PMDA (J-PRISM), Health Canada differences... |
| version | 1.0.0 |
| domain | D04 |
| domain_name | Individual Case Safety Reports |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain regional variations","what is regional variations","explain regional variations"] |
| epa_mapping | EPA-01, EPA-04, EPA-09 |
| cpa_mapping | CPA-01, CPA-04 |
| regulatory_refs | ICH-M1 (MedDRA), ICH-E2B(R3) |
KSB-D04-K0005: Regional Variations
Overview
Domain: D04 - Individual Case Safety Reports
Type: Knowledge
Proficiency Level: L1 (Novice - Direct supervision required)
Bloom Level: Understand
Description
FDA (FAERS), EMA (EudraVigilance), PMDA (J-PRISM), Health Canada differences
Context
- Major Section: Global Regulatory Requirements for ICSRs
- Section: International Harmonization Standards
EPA Mapping
- EPA-01:3001-3003
- EPA-04:3009-3010
- EPA-09:3020-3022
CPA Pathway
Regulatory References
- ICH-M1 (MedDRA)
- ICH-E2B(R3)
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in regional variations
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
- Connect to related EPAs: EPA-01, EPA-04, EPA-09
Key Competencies
- FDA (FAERS), EMA (EudraVigilance), PMDA (J-PRISM), Health Canada differences
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D04 skills in International Harmonization Standards
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
