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- TGA presentation: Innovate Health 2019, 27 June 2019
An overview of how Australia regulates medical devices, with a focus on software and digital health
- Webinar presentation: Proposed Reforms to the Regulation of Software, Including Software as a Medical Device - Consultation Results, 20 June 2019
Digital Devices Webinar 3
- TGA presentations: TGO 101 industry meeting, 13 May 2019
This presentation highlights some of the changes in Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019.
- TGA presentations: CMA Therapeutic Goods New Advertising Code and Complaints System Seminar, Sydney, 1 May 2019
An overview of the Therapeutic Goods Advertising Code (No.2) 2018, with examples to illustrate the application of key sections.
- TGA presentation: : MTAA Advertising Code basics presentation, 3 April 2019
This presentation is an overview of the Therapeutic Goods Advertising Code (No. 2) 2018.
- TGA presentation: Hunter New England Local Health District 3D Printing Forum, 30 March 2019
A narrated presentation on the Current Regulatory Landscape for Medical Device 3D-Printing, and Proposed Regulatory Reforms.
- Webinar presentation: Consultation on reforms to the generic medicine market authorisation process, 14 March 2019
Presentation to ARCS Australia members on 14 March 2019 on the scope and content of the consultation
- Webinar recording: SME Assist - Permitted indications for listed medicines, March 2019
This webinar is targeted at small to medium enterprises and any sponsor who is unfamiliar with the current permitted indication requirements
- Presentations: ARCS Australian Pharmacovigilance Regulatory Requirements and Risk Management Plans Summit, 27 March 2019
Presentations on regulatory requirements for pharmacovigilance and risk management plan compliance
- Presentation: Therapeutic Goods Advertising Code (No. 2) 2018, 15 March 2019
An overview of the Therapeutic Goods Advertising Code (No.2) 2018, with examples to illustrate the application of key sections
- Webinar presentation: Regulation of software, including software as a medical device, 7 March 2019
This presentation was given as a webinar on 7 March 2019. It discusses how the current regulatory scheme applies to software
- Webinar presentation: The role of the TGA in digital health, 7 February 2019
This presentation discusses where the TGA fits in the broader digital health environment
- Webinar recording: The Role of Digital Health, 7 February 2019
This webinar aims to clarify which technologies fall under TGA regulation, and introduces the work that is underway
- TGA presentation: Potential reforms for the regulation of system and procedure pack medical devices
This presentation highlights some of the concerns related to system or procedure pack medical devices
- Webinar presentation: TGA's Role in Clinical Trials Regulation and Administration, 6 December 2018
An overview of supplying 'unapproved' therapeutic goods in clinical trials
- Webinar recording: Medicine shortages reporting reforms, 28 November 2018
An overview of mandatory medicine shortages reporting obligations for sponsors to be implemented on 1 January 2019
- TGA presentation: Workshop - Changes to Advertising of Therapeutic Goods in Australia, Pharmacy Guild of Australia, 19 November 2018
Advertising legislation, summary of complaints handling and tips for pharmacies to ensure compliance
- TGA presentation: Webinar: Therapeutic Goods Advertising Code (No. 2) 2018, 20 November 2018
An overview of the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code) followed by details of the Code with examples.
- TGA presentation: Therapeutic Goods Advertising Code (No. 2) 2018 - The Code basics, 13 and 15 November 2018
A detailed walkthrough of the Code with examples to illustrate the application of the key sections.
- TGA presentation: Generic and Biosimilar Medicines Association (GBMA) meeting, 2 November 2018
Short presentation on the ACSS Consortium, the Generic Medicines Working Group and the Generic Medicines Work-Sharing Trial
- TGA presentations: ASMI Therapeutic Goods Advertising Seminar, 29 and 30 October 2018
An overview of the legislative framework that the TGA administers to regulate the advertising of therapeutic goods.
- TGA presentation: 8th Annual EyeforPharma Conference, 9 October 2018
Updates from the Therapeutic Goods Administration - for medicine sponsors
- Webinar recording: Fast track priority pathways, 27 September 2018
This webinar discusses priority review and provisional approval pathways
- Webinar recording: New warning statements on labels of Neuromuscular blocking agents, 13 September 2018
This webinar was for medical professionals who handle neuromuscular blocking agents, to inform them of the recent introduction of new label warning statements
- TGA presentations: CAPSIG Seminar, 12 September 2018
Overview of regulatory requirements introduced as part of PIC/s PE009-13 Guide to GMP and a summary of the new PI041-1 Data Integrity
- TGA presentations: 2018 ARCS Annual Conference, 21-23 August 2018
Presentations from the TGA on a variety of topics
- TGA presentation: UTS Molecule to Market, 15 August 2018
Pharmacovigilance from the regulator's perspective