| 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 |
KSB-D01-K0002: Regulatory Development
Overview
Domain: D01 - Foundations of Pharmacovigilance
Type: Knowledge
Proficiency Level: L1 (Novice - Direct supervision required)
Bloom Level: Understand
Description
Evolution from reactive post-market observation to proactive safety systems
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 L1 proficiency in regulatory development
- Apply understand level cognitive skills to explain the topic
- Reference relevant regulatory guidance (ICH-E2A, ICH-E2E, EMA-REG-001)
- Connect to related EPAs: EPA-01, EPA-10
Key Competencies
- Evolution from reactive post-market observation to proactive safety systems
Assessment Criteria
- Can explain 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
