Events

This webinar provides an overview of TGA’s Good Clinical Practice (GCP) Inspection Program clinical trial compliance activities.

Information session for external stakeholders about the proposed IVD regulation changes.

Are you interested in applying to be a member of one of the TGA’s Statutory Advisory Committees? Hear first-hand from current members and the Chief Medical Adviser about what this exciting role is like.

This is a Q&A Session for Industry about the recently published guidance on listed probiotic medicines.

View the proposed changes to the post-market review compliance portal allowing sponsors of exempt devices to view and respond to regulatory notices, and ask questions and provide feedback on the proposed changes.

Webinar giving an overview of the software reclassification reforms and the transitional arrangements for software based medical devices affected by the changes.

View the proposed changes to the on-line application form for consent to import, export, or supply medical devices that do not comply with the Essential Principles.

About the inclusion of medical devices to the GCP inspection program and the recent updates to the GCP inspection program guidance document in what to expect and how to prepare for an inspection. A recording of the webinar will be available.

We will provide an overview of the Medicines Repurposing Program and how interested stakeholders can propose potential new therapeutic uses of existing medicines.

We will provide an overview of the Medicines Repurposing Program and how interested stakeholders can propose potential new therapeutic uses of existing medicines.

This webinar provides information on the TGA’s public consultation on the impacts, challenges and opportunities relating to medicine shortages.

We provided an update on the Australian UDI implementation and a guest speaker presented on the real-world benefits of the UDI adoption in the US healthcare system. See the slides and video.

Update on what we know so far, next 6 - month plan and what you can do to get involved.

Learn about the new Medical Device Vigilance Program that we will be piloting, and volunteer to participate.

Webinar to understand recent changes to safety issue reporting requirements as outlined in the Pharmacovigilance responsibilities of medicine sponsors guidance.

Attend this webinar to understand recent changes to safety issue reporting requirements as outlined in the Pharmacovigilance responsibilities of medicine sponsors guidance.

UDI 17, 18 July 2023 Australian UDI update, workshop summary and AusUDID Pre-Production demonstration

UDI Webinar 16 – Australian UDI update and guest speakers on the value of UDI for procurement and inventory management in hospitals.

Changes to the formatting and structure of the Poisons Standard will come into effect from 1 February 2023

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.

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

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

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.

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