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.

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CEU Credits: 0.1
Course Code: ELM-935
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 04/18/2024

Curriculum for this course

Course Introduction
What is a Signal?
Sources of Data
Active Surveillance Systems
Data Management and Reporting of Adverse Reactions
Signal Validation and Further Assessment
Signal Validation Flow
Prioritizing Signals
Quality Requirements for Signal Management
Activity
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

v1.1 Minor update on 02/24/2025. Assessment question updated for clarity. Additionally, the course template was enhanced to provide more specific quiz completion data and a Version History document.
v1.0 Course released on 05/22/2024

Author

Ian Nicholls

Director at Explic8

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