Presentations

2021: Nov Oct Sep Aug Jul Jun Mar Feb May Jun

November 2021

Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 29 November 2021
Consent to supply medical devices that are non-compliant with the Essential Principles (EPs)
Medicinal cannabis - Changes to sponsor requirements for supplying unapproved medicinal cannabis products in Australia, 22 November 2021
Guiding you through your requirements as a sponsor of an unapproved medicinal cannabis product
Medicinal cannabis - Changes to Special Access Scheme (SAS) and Authorised Prescriber applications, 22 November 2021
Presentation explaining how medical practitioners can apply to access certain medicinal cannabis medicines via the Authorised Prescriber Established History of use pathway
Unique Device Identification Webinar #6 - 2021 Wrap-up and Q & A, 16 November 2021
A presentation on the current status of the work to establish the Australian UDI system, and questions and answers.

Cracking the code: Developing requirements for data matrix codes on medicines, 20 October 2021
A presentation on Cracking the code: Developing requirements for data matrix codes on medicines by Tony Manderson at the RACI PSG Conference
Nicotine vaping products, the UK smoking cessation experience, 20 October 2021
A presentation on Practical and clinical experience in the practice of smoking cessation treatments in the UK
Webinar 2: Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 20 October 2021
The TGA is modernising this process to move from a standalone paper-based form to an online form
Application for consent to import, supply, or export a medical device non-compliant with the Essential Principles, 19 October 2021
The TGA is modernising this process to move from a standalone paper-based form to an online form
Unique Device Identification Webinar #5, 19 October 2021
A presentation on the role of a UDI Issuing Agency, including project update and Q&A
Nicotine vaping products, the NZ smoking cessation experience, 15 October 2021
The role nicotine vaping products can play in a person's journey to quit
Pharmacovigilance - a regulator's perspective, 13 October 2021
This presentation delivered on behalf of the TGA to the students at the University Technology of Sydney as part of the Master of Pharmacy course

The role of a UDI Issuing Agency, 21 September 2021
Information on the creation of UDIs and the role of an Issuing Agency
An introduction to regulation of medical devices in Australia, 6 September 2021
Presentation from TGA Lecture at Biomedical engineering Department.

Challenges and considerations on the journey to a global UDI system, 17 August 2021
A presentation and Q&A on UDI from a perspective of a global medical technology company.

TGA Transformation Stakeholder Engagement Forums, 29 July 2021
The TGA is embarking on a transformation program to change and improve the way we deliver services to our stakeholders.
Considerations for the Australian UDI, 20 July 2021
Further considerations for the Australian UDI, including global alignment, GMDN and data elements.

Unique Device Identification, 15 June 2021
An introduction to the Australian Unique Device Identification system, including Q&A
Proposed improvements to the Therapeutic Goods Advertising Code, 3 June 2021
An overview of the key issues contained in the public consultation paper. The consultation is seeking feedback on options for improving the clarity and performance of the Code.

Medicinal cannabis advertising compliance, 18 March 2021
Advertising rules and responsibilities, including how they may affect the preparation of public facing communications and other activities.
Special Access Scheme Portal, 11 March 2021
Walkthrough changes to the SAS Category B forms and Authorised Application form.
TGO 110: Standard for unapproved vaporiser nicotine products, 4 March 2021
An overview of TGA's proposed safety and quality requirements for unapproved vaporiser nicotine products
Medicinal cannabis advertising compliance, 3 March 2021
Overview to assist industry and other interested parties to understand their obligations in regards to advertising medicinal cannabis.

The regulation of medical device software, February 2021
An overview of medical device software regulation in Australia.
Australian Dental Industry Association (ADIA), 16 February 2021
Overview of the new framework including regulatory concepts and worked examples for the dental industry
Australian Orthotic Prosthetic Association (AOPA), 16 February 2021
Overview of the new framework including regulatory terminology and worked examples
Personalised Medical Devices Framework
Guidance for industry on the new regulatory framework for personalised medical devices commencing on 25 February 2021.