| name | KSB-D12-K0047 |
| description | EMA-HMA AI Workplan 2025-2028: Comprehensive understanding of the EMA-HMA joint AI Workplan 2025-2028 including its four strategic ... |
| version | 1.0.0 |
| domain | D12 |
| domain_name | Industry & Regulatory |
| type | Knowledge |
| proficiency_level | L3 |
| bloom_level | apply |
| triggers | ["explain ema-hma ai workplan 2025-2028","what is ema-hma ai workplan 2025-2028","apply ema-hma ai workplan 2025-2028"] |
| epa_mapping | EPA-06, EPA-09, EPA-16 |
| cpa_mapping | CPA-04 |
| regulatory_refs | |
KSB-D12-K0047: EMA-HMA AI Workplan 2025-2028
Overview
Domain: D12 - Industry & Regulatory
Type: Knowledge
Proficiency Level: L3 (Competent - Minimal supervision)
Bloom Level: Apply
Description
Comprehensive understanding of the EMA-HMA joint AI Workplan 2025-2028 including its four strategic dimensions (guidance/policy/product support, tools/technologies, collaboration/change management, experimentation), Network Data Steering Group (NDSG) governance structure, AI Observatory horizon scanning function, and domain-specific pharmacovigilance AI guidance development timeline. Knowledge of workplan integration with EMRN Strategy 2028 and annual stakeholder consultation cycles.
Context
- Major Section: European AI Regulatory Framework
- Section: EMA-HMA AI Strategy
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 L3 proficiency in ema-hma ai workplan 2025-2028
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (general PV standards)
- Connect to related EPAs: EPA-06, EPA-09, EPA-16
Key Competencies
- Comprehensive understanding of the EMA-HMA joint AI Workplan 2025-2028 including its four strategic dimensions (guidance/policy/product support, tools/technologies, collaboration/change management, experimentation), Network Data Steering Group (NDSG) governance structure, AI Observatory horizon scanning function, and domain-specific pharmacovigilance AI guidance development timeline. Knowledge of workplan integration with EMRN Strategy 2028 and annual stakeholder consultation cycles.
Assessment Criteria
- Can apply core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D12 skills in EMA-HMA AI Strategy
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
