By 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
- CPA-04
Regulatory References
- General PV competency
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