Regulatory Development: Evolution from reactive post-market observation to proactive safety systems...
Regulatory Development: Evolution from reactive post-market observation to proactive safety systems...
npx skills add https://github.com/nexvigilant/.true --skill ksb-d01-k0002이 명령을 Claude Code에 복사하여 붙여넣어 스킬을 설치하세요
| name | KSB-D01-K0002 |
| description | Regulatory Development: Evolution from reactive post-market observation to proactive safety systems... |
| version | 1.0.0 |
| domain | D01 |
| domain_name | Foundations of Pharmacovigilance |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain regulatory development","what is regulatory development","explain regulatory development"] |
| 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
Evolution from reactive post-market observation to proactive safety systems
When this skill is activated, Claude should:
Generated from PV KSB Framework v1.0 | 2025-12-31
Auto-apply Knowledge-Skills-Behaviors framework to guide Claude's reasoning
Thalidomide Legacy: Understanding the pivotal 1960s tragedy that catalyzed modern pharmacovigilance...
Global Harmonization: ICH guidelines development and international regulatory convergence...
Technology Evolution: From paper-based reporting to AI-enhanced surveillance systems...
Population Health Impact: Understanding medication safety within broader public health frameworks...
Health Equity Considerations: Ensuring safety monitoring addresses diverse populations and access issues...
