Ksb D12 K0028

CPA Pathway

• CPA-04

Regulatory References

• FDA-CFR-004
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in organizational learning and adaptation
2. Apply create level cognitive skills to create the topic
3. Reference relevant regulatory guidance (FDA-CFR-004, EMA-REG-001)
4. Connect to related EPAs: EPA-06, EPA-09, EPA-16

Key Competencies

• Regulatory intelligence systems and organizational learning, best practice identification and knowledge management, continuous improvement culture and innovation, regulatory science career development and talent retention

Assessment Criteria

• Can create core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D12 skills in Regulatory Science Leadership and Organizational Capability Building
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31