Ksb D01 K0009

Regulatory References

• ICH-E2A
• ICH-E2E
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in fda guidance
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (ICH-E2A, ICH-E2E, EMA-REG-001)
4. Connect to related EPAs: EPA-01, EPA-10

Key Competencies

• Understanding FAERS, FDA's role in post-market surveillance, and regulatory expectations

Assessment Criteria

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

Related Skills

• Other D01 skills in Regulatory Framework Foundations
• Cross-domain integrations per DAG architecture

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