Ksb D05 K0003

• CPA-01, CPA-07

Regulatory References

• EMA-REG-004
• ICH-E6

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in eu clinical trial regulation
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (EMA-REG-004, ICH-E6)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-08

Key Competencies

• Regulation (EU) No 536/2014 implementation, safety reporting timelines, and CTIS integration

Assessment Criteria

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

Related Skills

• Other D05 skills in International Regulatory Harmonization
• Cross-domain integrations per DAG architecture

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