ksb-d01-k0010

name: "KSB-D01-K0010" description: "EMA Framework: EU Pharmacovigilance legislation, GVP modules, and European regulatory approach..." version: "1.0.0" domain: "D01" domain_name: "Foundations of Pharmacovigilance" type: "Knowledge" proficiency_level: "L1" bloom_level: "understand" triggers: - "explain ema framework" - "what is ema framework" - "explain ema framework" epa_mapping: "EPA-01, EPA-10" cpa_mapping: "CPA-01" regulatory_refs: "ICH-E2A, ICH-E2E, EMA-REG-001"

KSB-D01-K0010: EMA Framework

Overview

Domain: D01 - Foundations of Pharmacovigilance Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Understand

Description

EU Pharmacovigilance legislation, GVP modules, and European regulatory approach

Context

• Major Section: Historical Evolution and Context
• Section: Regulatory Framework Foundations

EPA Mapping

• EPA-01:3001-3003
• EPA-10:3023-3024

CPA Pathway

• CPA-01

Regulatory References

• ICH-E2A
• ICH-E2E
• EMA-REG-001

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in ema framework
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

• EU Pharmacovigilance legislation, GVP modules, and European regulatory approach

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