Ksb D04 K0006

Regulatory References

• ICH-M1 (MedDRA)
• ICH-E2B(R3)

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in 15-day safety reports
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (ICH-M1 (MedDRA), ICH-E2B(R3))
4. Connect to related EPAs: EPA-01, EPA-04, EPA-09

Key Competencies

• Serious, unexpected adverse events in marketed products

Assessment Criteria

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

Related Skills

• Other D04 skills in Expedited Reporting Requirements
• Cross-domain integrations per DAG architecture

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