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.

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.

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

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

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.

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.

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

This webinar will outline what regulatory actions are required as a result of changes under the EU MDR, and how the TGA will streamline the transition.

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)

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.

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

Using UDIs in healthcare - real world experience.