Events

Presentations from the GMP Forum 2021 have been published.

A presentation and Q&A on UDI from a perspective of a global medical technology company.

Common deficiencies and FAQs from the GMP inbox.

An overview of GMP compliance signals, how we manage these signals for manufacturers of medicines and biologicals and the kind of information that may be required in the assessment of these signals.

Webinar presentation on regulatory flexibilities and performance during the pandemic.

Further considerations for the Australian UDI, including global alignment, GMDN and data elements.

A webinar about manufacturing quality perspective.

TGA presentation slides from Queensland Cardiovascular Research Network Webinar (25 June 2021).

An introduction to the Australian Unique Device Identification system

EU Medical Device Regulation changes and the implications for the TGA and Australia

TGA presentation slides from Virtual Public-Private Dialogue (PPD) on Biotechnological products in partnership with Peru INS (11 May 2021).

Special Access Scheme - portal updates.

An overview of TGA's proposed safety and quality requirements for unapproved vaporiser nicotine products.

Guidance for industry on the new regulatory framework for personalised medical devices commencing on 25 February 2021.

SME Assist's 'Meeting Your Obligations' workshop - Live stream - 22 October 2020 has now been published.

This presentation provides an overview of TGA's comparable overseas regulator pathways and international work-sharing activities for prescription medicines.

Remote Inspections from TGA perspective - Impact of Covid-19 Restrictions on Manufacturers and Test Laboratories.

Information session for consumers and health practitioners on proposed changes to the way nicotine is supplied.

Information session for consumers and health practitioners on proposed changes to the way nicotine is supplied.

Information session for suppliers on proposed changes to the way nicotine is supplied.

Webinar presentation, recordings and frequently asked questions to explain the proposed changes to the way nicotine is supplied.

A panel discussion was held in Sydney to talk about BIA-ALCL and breast reconstructive surgery. The recording of this discussion is below.

A panel discussion was held in Sydney to talk about BIA-ALCL and breast augmentations. The recording of this discussion is below.

Registration open

An overview of medical device software regulation in Australia