Ksb D08 K0038

• CPA-02

Regulatory References

• FDA-GUID-006
• EMA-GVP-005
• EMA-GVP-010
• CIOMS-VIII

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in healthcare provider communication
2. Apply create level cognitive skills to create the topic
3. Reference relevant regulatory guidance (FDA-GUID-006, EMA-GVP-005, EMA-GVP-010, CIOMS-VIII)
4. Connect to related EPAs: EPA-04, EPA-05

Key Competencies

• Clinical advisory development, prescriber notification systems, patient counseling material creation, continuing education program design

Assessment Criteria

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

Related Skills

• Other D08 skills in Stakeholder Communication and Regulatory Interface
• Cross-domain integrations per DAG architecture

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