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.

CEU Credits: 0.1
Course Code: ELM-934
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 24/04/2024

Curriculum for this course


What is PSUR?
41 secs
What does a PSUR do?
24 secs
What does "periodic" mean?
36 secs
1 min 9 secs
Introductory sections
57 secs
Estimated exposure and use patterns
44 secs
Data in summary tabulations
13 secs
Signifigant findings summary
1 min
Findings from non-interventional studies
53 secs
Miscellaneous sections
28 secs
Signal and risk evaluation
32 secs
5 secs
Benefit evaluation
57 secs
Integrated risk-benefit analysis
41 secs
Conclusions, actions and appendices
30 secs
Post-authorization safety studies
46 secs



Test Your Knowledge


Revision History


Ian Nicholls

Director at Explic8


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