Events

The purpose of this webinar was to help sponsors understand how to use the Listed Medicines Evidence Guidelines to compile a robust evidence package that supports the efficacy of their listed medicine.

Presentation at the RACI Pharmaceutical Science Group (NSW) Seminar/Webinar, information for manufacturers of medicinal products on Computerised Systems - establishing and maintaining data integrity

A webinar covering how to view and respond to notifications in the Consent for Non-compliance Dashboard

This webinar will cover the process of submitting evidence of compliance with the EPs for devices in a consent application in a live demonstration.

A webinar covering medical device that are non-compliant with the Essential Principles (EPs)

This webinar will guide you through the process of applying for consent to import, supply or export a medical device non-compliant with the Essential Principles (EPs)

Guest speakers from Zebra Technologies will share observations and learnings from the UK Scan4Safety pilot.

Guest speakers from Zebra Technologies will share observations and learnings from the UK Scan4Safety pilot.

This webinar provides information on the third UDI Consultation Paper and runs through the submission process. It also includes a project update and question-and-answer session.

Understand the key findings of the independent expert report on the risks of intentional self-poisoning with paracetamol and have your questions answered about the TGA’s consultation (starting mid-September) on the possible options for changing access or purchasing controls through the Poisons Standard.

A webinar on the key findings from the independent expert report on the risks of intentional self-poisoning with paracetamol and options for amending the Poisons Standard

Insight into the role and expectations of committee members.

Information for manufacturers, sponsors and users of the UDI data on how to access the AusUDID Sandpit

Information for manufacturers, sponsors and users of the UDI data on how to access the AusUDID Sandpit

Information for manufacturers, sponsors and users of UDI data on how to access the AusUDID Sandpit

To raise awareness and engage with potential website users about the TGA website redevelopment and release.

Information for manufacturers, sponsors and users of UDI data on how to access the AusUDID Sandpit.

Significant safety issue reporting - Changes to the Pharmacovigilance guidelines for sponsors.

Improving healthcare with data collected from medicine and vaccine adverse event reporting.

Real world evidence in the regulation of medical devices.

A presentation on current activities, collaborations, and performance of the Prescription Medicine Authorisation Branch.

Post Market Surveillance - Considerations for medial device sponsors.

The increasing availability of Real World Evidence presents opportunities to improve treatments and repurpose medicines.

Updates on regulatory framework and key activities from the TGA's Medical Devices Authorisation Branch.

Updates on regulatory pathways for gene therapy products in Australia.