CEU Credits: 0.1
Course Code: ELM-934
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
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
Minor Update: Course updated to clarify the history and use of PBRER.
V1.1
