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EMA Framework: EU Pharmacovigilance legislation, GVP modules, and European regulatory approach...
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Showing SKILL.md
| name | KSB-D01-K0010 |
| description | EMA Framework: EU Pharmacovigilance legislation, GVP modules, and European regulatory approach... |
| version | 1.0.0 |
| domain | D01 |
| domain_name | Foundations of Pharmacovigilance |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain ema framework","what is ema framework","explain ema framework"] |
| epa_mapping | EPA-01, EPA-10 |
| cpa_mapping | CPA-01 |
| regulatory_refs | ICH-E2A, ICH-E2E, EMA-REG-001 |
Domain: D01 - Foundations of Pharmacovigilance Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand
EU Pharmacovigilance legislation, GVP modules, and European regulatory approach
When this skill is activated, Claude should:
Generated from PV KSB Framework v1.0 | 2025-12-31
