Safety through adverse event reporting - share the responsibility
Safety through adverse event reporting - share the responsibility
This interactive online learning supports health professionals to report adverse events associated with medicines and vaccines, contributing to the TGA’s ongoing safety monitoring.
Key features of this learning activity include a detailed explanation of why it's important to report adverse events, how to report and what to report. The units explain what happens to reports once they are submitted to the TGA and how they are used to improve safety for all Australians.
The units have been designed to build on health professionals current knowledge and experience while promoting a deeper understanding of why patients and the TGA rely on health professionals reporting adverse events.
This activity has been developed with funding from the Therapeutic Goods Administration, Australian Government Department of Health and Aged Care.
Learning objectives
Unit 1: Why should you report?
After completing this unit, you should be able to:
- Explain the importance of adverse event reporting in ensuring medicines and vaccines are safe and effective in Australia.
- Describe the role of the TGA in collecting and responding to adverse event reports.
Unit 2: What should you report?
After completing this unit, you should be able to:
- Identify which adverse events to report.
- Explain how a well-documented adverse event report can help the TGA assess causality.
- Explain what to report for adverse events following immunisation.
- Explain the meaning of the black triangle symbol.
Unit 3: How should you report?
After completing this unit, you should be able to:
- Confidently submit an adverse event report.
- Describe the options for reporting an adverse event to the TGA
- Explain the TGA information requirements.
- Describe the benefits of becoming a registered reporter.
New - updated course available now!
CPD points and practice incentives
Continuing professional development
Self-directed CPD
Reporting adverse events to medicines and vaccines
It is recommended that 1 CPD hour be recorded for the purposes of self-directed CPD.
