Good Pharmacovigilance Practices (GVP)

GVP Signal Management

This course on Good Pharmacovigilance Practice (GVP) signal management is designed to equip pharmaceutical professionals with the knowledge and skills required to effectively manage safety signals. Participants will delve into the principles of signal detection, evaluation, prioritization, and management within the context of pharmacovigilance regulations and industry best practices.

CEU Credits: 0.1
Course Code: ELM-935
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 18/04/2024

Curriculum for this course


Course Introduction

What is a Signal?
40 secs
Sources of Data
50 secs
Active Surveillance Systems
45 secs
Data Management and Reporting of Adverse Reactions
30 secs
Signal Validation and Further Assessment
50 secs
Signal Validation Flow
30 secs
Prioritizing Signals
1 min
Quality Requirements for Signal Management
45 secs
30 secs
Statistical Methods
35 secs
Reporting Frequency
30 secs
Specific Groups of Adverse Events
50 secs
Methods for Specific Patient Populations
50 secs
Specific Circumstances of Medicine Use
25 secs

Case Study



Test Your Knowledge


Revision History


Ian Nicholls

Director at Explic8


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