Safety through reporting
Reporting adverse events with medicines and vaccines
Learning outcomes
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
Learning outcomes
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.
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