By 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
- CPA-01
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