Safety through reporting - share the responsibility
Safety through reporting - share the responsibility
These interactive online learning modules have been designed to support health professionals to report adverse events associated with therapeutic products and contribute to the TGA’s ongoing safety monitoring activities.
Key features of this suite of learning include a detailed explanation of the importance of reporting adverse events in an increasingly active health system, how to build reporting into practice and what happens to reports once they are submitted to the TGA.
The modules 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 to report adverse events.
This activity has been developed with funding from the Therapeutic Goods Administration, Australian Government Department of Health.
View the learning outcomes.
Enrolments for this training have ended and the courses will not be available after the 26th March while the TGA updates them. Your completion certificates will continue to be available.
Learning outcomes
Reporting adverse events with medicines and vaccines
On completion of this module you should be able to:
- Explain the importance of post-marketing surveillance in ensuring medicines are safe and effective and describe your role in pharmacovigilance activities such as adverse event reporting.
- Identify which adverse events require reporting and describe the reporting process for medicines and vaccines.
- Complete an adverse event report and explain why the requested information is important for the TGA.
- Summarise the regulatory system for reporting adverse events associated with vaccines and explain how this differs to that for medicines.
- Implement a reporting system for your practice based on what you have learnt in this module.
Reporting adverse events with medical devices
On completion of this module you should be able to:
- Explain the importance of post-marketing surveillance in ensuring medical devices are safe and effective and describe your role in post-marketing safety activities such as adverse event reporting.
- Identify which adverse events require reporting and describe the reporting process for medical devices.
- Complete an adverse event report and explain why the requested information is important for the TGA.
- Summarise the regulatory system for reporting adverse events associated with medical devices and explain how this differs to that for medicines.
- Implement a reporting system for your practice based on what you have learnt in this module.
CPD points and practice incentives
Continuing professional development
Self-directed CPD
Reporting adverse events with medicines and vaccines
It is recommended that 1 CPD hour be recorded for the purposes of self-directed CPD.
Reporting adverse events with medical devices
It is recommended that 1 CPD hour be recorded for the purposes of self-directed CPD.
