Events

Presented at the 2023 ARCS Annual Conference

Presented at the 2023 ARCS Annual Conference

Presented at the 2023 ARCS Annual Conference

Presented at the 2023 ARCS Annual Conference

Presented at the 2023 ARCS Annual Conference

The TGA Good Manufacturing Practice Forum returned to Sydney on 21 March 2023.

This webinar will address the recent announcement by the TGA that medicines containing psilocybin and MDMA will be conditionally classified as Schedule 8 (controlled drug) in the Poisons Standard.

This webinar will explain labelling requirements for finished MCP in detail.

This webinar will guide you through the process of charging for regulatory activities, the medicinal cannabis funding model and the fees and charges structure and amounts proposed to commence on 1 July 2023.

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

Presentation on the new formatting and structure of the Poisons Standard

This is the second in a series of three educational webinars outlining what regulatory actions are required as a result of changes under the EU MDR, with a focus on manufacturer evidence and variations to the ARTG.

This is the first in a series of three educational webinars outlining what regulatory actions are required as a result of changes under the EU MDR.

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

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

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.

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

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

Information for manufacturers, sponsors and users of the 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.