| name | KSB-D12-K0048 |
| description | EU AI Act Pharmacovigilance Implications: Mastery of EU AI Act requirements applicable to pharmacovigilance including risk classification cate... |
| version | 1.0.0 |
| domain | D12 |
| domain_name | Industry & Regulatory |
| type | Knowledge |
| proficiency_level | L4 |
| bloom_level | analyze |
| triggers | ["explain eu ai act pharmacovigilance implications","what is eu ai act pharmacovigilance implications","analyze eu ai act pharmacovigilance implications"] |
| epa_mapping | EPA-06, EPA-09, EPA-16 |
| cpa_mapping | CPA-04 |
| regulatory_refs | |
KSB-D12-K0048: EU AI Act Pharmacovigilance Implications
Overview
Domain: D12 - Industry & Regulatory
Type: Knowledge
Proficiency Level: L4 (Proficient - Independent practice)
Bloom Level: Analyze
Description
Mastery of EU AI Act requirements applicable to pharmacovigilance including risk classification categories for AI systems, conformity assessment obligations, transparency requirements for automated decision-making, and post-market monitoring expectations. Understanding of high-risk AI system designation criteria relevant to drug safety, documentation requirements under Annex IV, and EMA preparations for AI Act implementation in medicines regulation.
Context
- Major Section: European AI Regulatory Framework
- Section: EU AI Act Compliance
EPA Mapping
- EPA-06:3013-3015
- EPA-09:3020-3022
- EPA-16:3035-3036
CPA Pathway
Regulatory References
Instructions
When this skill is activated, Claude should:
- Demonstrate L4 proficiency in eu ai act pharmacovigilance implications
- Apply analyze level cognitive skills to analyze the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-06, EPA-09, EPA-16
Key Competencies
- Mastery of EU AI Act requirements applicable to pharmacovigilance including risk classification categories for AI systems, conformity assessment obligations, transparency requirements for automated decision-making, and post-market monitoring expectations. Understanding of high-risk AI system designation criteria relevant to drug safety, documentation requirements under Annex IV, and EMA preparations for AI Act implementation in medicines regulation.
Assessment Criteria
- Can analyze core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D12 skills in EU AI Act Compliance
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
