This free course will guide you through the adverse event reporting process. Reporting adverse events is important to ensure that therapeutic products continue to be safe.
About
Reporting adverse events is important to ensure that therapeutic products including medicines, vaccines and medical devices continue to be safe. This ultimately ensures you have the most up to date safety information available when you are treating patients.
By reporting adverse events to the Therapeutic Goods Administration (TGA) patient safety issues can be addressed. The TGA relies on all health professionals to be vigilant and share this important responsibility.
In partnership with the TGA, NPS MedicineWise has developed two modules to update prescribers and other health professionals on what constitutes a reportable adverse event with medicines, vaccines and medical devices, and what steps you need to take to report.
- Module 1: Reporting adverse events with medicines and vaccines
- Module 2: Reporting adverse events with medical device
Learning outcomes
Module 1: 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.
Module 2: 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 from that for medicines
- implement a reporting system for your practice based on your learnings.