Good Pharmacovigilance Practices (GVP)

GVP PSUR (Periodic Safety Update Reports)

This course equips you with the knowledge and skills to navigate Periodic Safety Update Reports (PSURs) within the framework of the European Medicines Agency (EMA) guidelines.

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CEU Credits: 0.1
Course Code: ELM-934
Duration: 15 mins
Skill Level: Intermediate
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 04/24/2024

Curriculum for this course

Welcome

What is PSUR?
What does a PSUR do?
What does "periodic" mean?
PSUR vs PBRER
Introductory sections
Estimated exposure and use patterns
Data in summary tabulations
Signifigant findings summary
Findings from non-interventional studies
Miscellaneous sections
Signal and risk evaluation
Activity
Benefit evaluation
Integrated risk-benefit analysis
Conclusions, actions and appendices
Post-authorization safety studies

Conclusion

Summary

Test Your Knowledge

v1.2 Minor update on 04/28/2026 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.
V1.1 Minor Update: Course updated to clarify the history and use of PBRER.
v1.0 Course released on 05/31/2024

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