ksb-d06-k0044

name	KSB-D06-K0044
description	Post-Market Surveillance: AI-enhanced detection of quality issues from adverse event reports and complaints...
version	1.0.0
domain	D06
domain_name	Medication Errors & Quality
type	Knowledge
proficiency_level	L1
bloom_level	understand
triggers	["explain post-market surveillance","what is post-market surveillance","explain post-market surveillance"]
epa_mapping	EPA-01, EPA-07, EPA-09
cpa_mapping	CPA-01, CPA-03
regulatory_refs	FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003

KSB-D06-K0044: Post-Market Surveillance

Overview

Domain: D06 - Medication Errors & Quality Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

AI-enhanced detection of quality issues from adverse event reports and complaints

Context

• Major Section: Comprehensive Medication Error Taxonomy and Classification
• Section: Quality Defect Detection and Management

EPA Mapping

• EPA-01:3001-3003
• EPA-07:3016-3017
• EPA-09:3020-3022

CPA Pathway

• CPA-01, CPA-03

Regulatory References

• FDA-CFR-001
• FDA-CFR-003
• ICH-E2A
• ICH-E2B(R3)
• ICH-E2D
• EMA-GVP-003

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in post-market surveillance
2. Apply understand level cognitive skills to explain the topic
3. Reference relevant regulatory guidance (FDA-CFR-001, FDA-CFR-003, ICH-E2A, ICH-E2B(R3), ICH-E2D, EMA-GVP-003)
4. Connect to related EPAs: EPA-01, EPA-07, EPA-09

Key Competencies

• AI-enhanced detection of quality issues from adverse event reports and complaints

Assessment Criteria

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

Related Skills

• Other D06 skills in Quality Defect Detection and Management
• Cross-domain integrations per DAG architecture

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