Ksb D12 K0047

• 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:

1. Demonstrate L3 proficiency in ema-hma ai workplan 2025-2028
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (general PV standards)
4. 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