Ksb D14 K0010

• CPA-06

Regulatory References

• FDA-GUID-001
• ICH-E2E
• EMA-REG-001
• EMA-REG-002
• EMA-GVP-001
• EMA-GVP-006

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in external partnership communication
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-GUID-001, ICH-E2E, EMA-REG-001, EMA-REG-002, EMA-GVP-001, EMA-GVP-006)
4. Connect to related EPAs: EPA-03

Key Competencies

• Communication strategies for managing relationships with academic institutions, technology vendors, advocacy groups, and other external partners, including collaborative project communication and reputation management.

Assessment Criteria

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

Related Skills

• Other D14 skills in Stakeholder-Specific Communication
• Cross-domain integrations per DAG architecture

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