Good Pharmacovigilance Practices (GVP)

The Fundamentals of Good Pharmacovigilance Practices (GVP)

“The Fundamentals of Good Pharmacovigilance Practices (GVP)” is a basic level course providing the foundation of what pharmacovigilance is and what adverse drug reactions are. The course provides a high-level overview for those just getting started in GVP or those needing a refresher.

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CEU Credits: 0.1

Course Code: ELM-920

Duration: 20 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: V2.1

Effective Date: 02/29/2024

Curriculum for this course

Welcome

Course Introduction

What is Pharmacovigilance and Why is it Needed?

Goals

Objectives

Knowledge Check

Adverse Drug Reaction (ADR)

Impacts of Adverse Drug Reaction (ADR)

Classification of Adverse Drug Reaction (ADR) - Frequency

Classification of Adverse Drug Reaction (ADR) - Type

Adverse Drug Reaction (ADR) Reporting

Pharmacovigilance vs ADR

A Global Initative

Types of Reports

Report Validation

Follow Up and Data Management

Summary

Test Your Knowledge

Revision History

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