Good Pharmacovigilance Practices (GVP)

GVP Risk Management Systems

This course allows learners to gain a thorough understanding of Good Pharmacovigilance Practices (GVP) by exploring the process of building a robust risk management plan. Learn to identify products requiring a plan, understand its structure, and develop effective risk minimization tools. This course is ideal for life science professionals involved in pharmacovigilance activities and anyone seeking a deeper understanding of GVP risk management.

CEU Credits: 0.1

Course Code: ELM-933

Duration: 10 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Effective Date: 06/20/2023

Curriculum for this course

Welcome

Course Introduction

GVP Across the Globe

The FDA Approach

FDA Cont.

The EU Approach

Collecting and Managing ADRs

Managing Duplicate Suspected Adverse Reaction Reports

Duplicates - Small vs Large Databases

Risk Management Principles and Parties

Matching Activity

Risk Management Plan

Risk Management Principles and Parties

Parts of the RMP

Part 1

Part 2

Part 3

Part 4

Part 5

Part 6

Part 7

Summary

Test Your Knowledge

Results

Revision History

Author

Ian Nicholls

Director at Explic8

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