ksb-d01-k0007

name: "KSB-D01-K0007" description: "Pandemic Preparedness: Role of pharmacovigilance in emergency use authorizations and vaccine safety..." version: "1.0.0" domain: "D01" domain_name: "Foundations of Pharmacovigilance" type: "Knowledge" proficiency_level: "L1" bloom_level: "apply" triggers: - "explain pandemic preparedness" - "what is pandemic preparedness" - "apply pandemic preparedness" epa_mapping: "EPA-01, EPA-10" cpa_mapping: "CPA-01" regulatory_refs: "ICH-E2A, ICH-E2E, EMA-REG-001"

KSB-D01-K0007: Pandemic Preparedness

Overview

Domain: D01 - Foundations of Pharmacovigilance Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Apply

Description

Role of pharmacovigilance in emergency use authorizations and vaccine safety

Context

• Major Section: Historical Evolution and Context
• Section: Public Health Integration

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:

1. Demonstrate L1 proficiency in pandemic preparedness
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (ICH-E2A, ICH-E2E, EMA-REG-001)
4. Connect to related EPAs: EPA-01, EPA-10

Key Competencies

• Role of pharmacovigilance in emergency use authorizations and vaccine safety

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D01 skills in Public Health Integration
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31