Fundamentals Series

The Fundamentals of Good Pharmacovigilance Practices (GVP)

ELM-920 The Fundamentals of Good Pharmacovigilance Practices (GVP) begins by immersing you in a hunt to separate GVP monitoring system noise from critical signals to protect patients. Through interactive simulations and informative examples, you’ll gain a firm grasp of the difference between Adverse Events (AEs) from Adverse Drug Reactions (ADRs) and how safety “signals” are managed. We’ll also explore the Pharmacovigilance System Master File (PSMF), risk minimization strategies, and the critical differences between internal audits and regulatory inspections to ensure global patient safety and continuous market access.

CEU Credits: 0.1
Course Code: ELM-920
Duration: 15 mins
Skill Level: Basic
Final Exam: Yes
Certification: Yes
Version: v3.0
Effective Date: 05/06/2026

Curriculum for this course

The Pattern Hunter
GVP & GMP
The Regulatory Landscape
Beyond the Individual
The Living Profile
AE and ADR
The Flow of Information
Signal or Noise?
Signal Management
Risk Minimization
Our Safety Script
Inspections vs. Audits
Incoming Audit!
A Unified, Compliant Quality Chain
Test your Knowledge!
v3.0 | Major Update on 8/11/2026. This course has been redesigned. The redesign includes updated learning objectives and content. The visual design has also been updated.
v2.1 | Minor update on 1/31/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
v2.0 | Major update on 02/29/2024. This course has been redesigned. The course content, objectives and visual design have been updated to reflect current best practices surrounding The Fundamentals of Good Pharmacovigilance
v1.4 | Minor update on 02/16/2024 to improve learning objectives and exam questions
v1.2 | Minor update on 04/10/2023 to fix a typo
v1.1 | Minor update on 12/08/2022 to fix assessment functionality
v1.0 | Course released in 2021

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