Ksb D11 K0011

CPA Pathway

• CPA-03

Regulatory References

• FDA-STAT-002
• EMA-GVP-002
• EMA-GVP-012
• UK-MHRA-009

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in international risk management requirements
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-STAT-002, EMA-GVP-002, EMA-GVP-012, UK-MHRA-009)
4. Connect to related EPAs: EPA-07, EPA-08, EPA-16

Key Competencies

• FDA REMS methodology, EU additional risk minimization measures, Health Canada risk management planning, Japanese post-marketing surveillance requirements

Assessment Criteria

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

Related Skills

• Other D11 skills in Global Regulatory Framework and Policy Integration
• Cross-domain integrations per DAG architecture

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