Ksb D12 K0010

• EPA-06:3013-3015
• EPA-09:3020-3022
• EPA-16:3035-3036

CPA Pathway

• CPA-04

Regulatory References

• FDA-CFR-004
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in crisis management and regulatory response
2. Apply remember level cognitive skills to define 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

• Safety signal response and regulatory communication, product recall management and regulatory coordination, inspection management and regulatory relationship preservation, crisis communication and stakeholder engagement

Assessment Criteria

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

Related Skills

• Other D12 skills in Strategic Regulatory Relationship Management and Organizational Excellence
• Cross-domain integrations per DAG architecture

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