| name | KSB-D11-K0011 |
| description | International Risk Management Requirements: FDA REMS methodology, EU additional risk minimization measures, Health Canada risk management planni... |
| version | 1.0.0 |
| domain | D11 |
| domain_name | Risk Management |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain international risk management requirements","what is international risk management requirements","explain international risk management requirements"] |
| epa_mapping | EPA-07, EPA-08, EPA-16 |
| cpa_mapping | CPA-03 |
| regulatory_refs | FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009 |
KSB-D11-K0011: International Risk Management Requirements
Overview
Domain: D11 - Risk Management
Type: Knowledge
Proficiency Level: L1 (Novice - Direct supervision required)
Bloom Level: Understand
Description
FDA REMS methodology, EU additional risk minimization measures, Health Canada risk management planning, Japanese post-marketing surveillance requirements
Context
- Major Section: Risk Management Theoretical Foundation and Implementation Science
- Section: Global Regulatory Framework and Policy Integration
EPA Mapping
- EPA-07:3016-3017
- EPA-08:3018-3019
- EPA-16:3035-3036
CPA Pathway
Regulatory References
- FDA-STAT-002
- EMA-GVP-002
- EMA-GVP-012
- UK-MHRA-009
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in international risk management requirements
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009)
- Connect to related EPAs: EPA-07, EPA-08, EPA-16
Key Competencies
- FDA REMS methodology, EU additional risk minimization measures, Health Canada risk management planning, Japanese post-marketing surveillance requirements
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D11 skills in Global Regulatory Framework and Policy Integration
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
