Events

This session provided an overview of the public consultation on the proposed amendments to the conformity assessment procedures for medical devices.

This presentation provides a background on our digital transformation and a walkthrough of the Beta (demonstration) version of the new TGA business services portal.

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

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 showcased changes to the Clinical Trials Notifications (CTN) form and explained how the review of CTNs for the highest risk medical device clinical trials will operate in practice.

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.

Learn about vaping reforms and how these will impact consumers, suppliers and health professionals.

An update on the Australian UDI implementation, and the real-world benefits of the UDI adoption in the US healthcare system.

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.

Register to hear insights from our Good Clinical Practice Inspection Program.

This presentation provides an update on the GCP Inspection Program implemented in 2022.

This presentation provides an update on the Australian UDI update, workshop summary and AusUDID Pre-Production demonstration.

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

This webinar will address the recent announcement by the TGA that medicines containing psilocybin and MDMA will be classified as Schedule 8 (controlled drug) when prescribed by a psychiatrist.

In this webinar we will provide an update on the Australian UDI implementation and discuss the challenges and benefits of having UDI in healthcare and the role of hospitals and other healthcare providers in relation to using UDI.

The final webinar in this series will explore the impact changes to the EU MDR will have on consent to supply and market notifications.

This webinar will focus on how the changes under the EU MDR will affect manufacturer evidence and variations to the ARTG.