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: 04/18/2024

Curriculum for this course

Welcome

Course Introduction

Signal Management Overview

What is a Signal?

Sources of Data

Active Surveillance Systems

Data Collection

Data Management and Reporting of Adverse Reactions

Signal Validation and Further Assessment

Signal Validation Flow

Prioritizing Signals

Quality Requirements for Signal Management

Activity

Methodology on Signal Detection

Statistical Methods

Reporting Frequency

Specific Groups of Adverse Events

Methods for Specific Patient Populations

Specific Circumstances of Medicine Use

Case Study

Conclusion

Summary

Test Your Knowledge

Results

Revision History

Author

Ian Nicholls

Director at Explic8

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