| name | KSB-D01-K0003 |
| description | Global Harmonization: ICH guidelines development and international regulatory convergence... |
| version | 1.0.0 |
| domain | D01 |
| domain_name | Foundations of Pharmacovigilance |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | create |
| triggers | ["explain global harmonization","what is global harmonization","create global harmonization"] |
| epa_mapping | EPA-01, EPA-10 |
| cpa_mapping | CPA-01 |
| regulatory_refs | ICH-E2A, ICH-E2E, EMA-REG-001 |
KSB-D01-K0003: Global Harmonization
Overview
Domain: D01 - Foundations of Pharmacovigilance
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Create
Description
ICH guidelines development and international regulatory convergence
Context
- Major Section: Historical Evolution and Context
- Section: Historical Evolution and Context
EPA Mapping
- EPA-01:3001-3003
- EPA-10:3023-3024
CPA Pathway
Regulatory References
- ICH-E2A
- ICH-E2E
- EMA-REG-001
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in global harmonization
- Apply create level cognitive skills to create the topic
- Reference relevant regulatory guidance (ICH-E2A, ICH-E2E, EMA-REG-001)
- Connect to related EPAs: EPA-01, EPA-10
Key Competencies
- ICH guidelines development and international regulatory convergence
Assessment Criteria
- Can create core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D01 skills in Historical Evolution and Context
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
