| 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
Regulatory References
- ICH-E2A
- ICH-E2E
- EMA-REG-001
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in pandemic preparedness
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (ICH-E2A, ICH-E2E, EMA-REG-001)
- 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
