12 December 2017
- Presentations: Codeine up-scheduling workshops, Melbourne, 28 November 2017
The TGA held a series of workshops on the up-scheduling of codeine
- TGA Presentations: Complementary medicine reforms information sessions, November-December 2017
An overview and update of the progress of complementary medicine reforms
- TGA presentation: The ACSS Consortium and the Generic Medicines Work-Sharing Trial, 16 November 2017
The Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial
- TGA presentation: Notifications to prescription medicines, 10 November 2017
New notifications process for minor variations to prescription medicines
- TGA presentations: Evaluation Panel Roadshow, November 2017
Evaluation Panel Roadshow information for prospective evaluators for the TGA.
- TGA presentation: RACGP (GP17) conference, 26-28 October 2017
Presentations given at: RACGP (GP17) conference held 26-28 October 2017
- TGA presentation: Complementary Medicines Regulatory (CMA) Annual Conference, 26 October 2017
Update on Reforms to the Regulatory Framework for Complementary Medicines.
- TGA presentation: 7th Annual EyeforPharma Conference, 11 October 2017
Update on initiatives relevant to prescription medicines and expedited pathways and transparency.
- TGA presentations: Devices Sponsor Information Day, 11 October 2017
Presentations by TGA and Industry (combined) to help sponsors and manufacturers better understand the regulation of medical devices and in-vitro diagnostic medical devices.
- TGA presentations: TGA Pharmacovigilance Inspection Program information sessions Sept-Oct 2017
Preparing for inspections, inspection process, and close out of inspections.
- TGA presentation: International Society for Cellular Therapy (Australia and New Zealand region), 15 September 2017
Overview of Biologicals framework updates
- TGA presentation: GMP clearance information session, 5-7 September 2017
An overview of the improvements made to the GMP clearance process including the revised guidance.
- TGA presentation: RACI and CAPSIG societies, 16 August 2017
Overview of the GMP regulations specific to cleaning validation for medicine manufacturers.
- TGA presentations: 2017 ARCS Annual Conference, 22-24 August 2017
Presentations from the TGA on a variety of topics
- TGA presentations: 2017 Pharmaceutical Society of Australia Conference (PSA17), 30 July 2017
Two presentations on recent and current reforms to prescription medicines regulation in Australia
- TGA presentations: Industry information and consultation sessions on medicinal cannabis - Adelaide and Brisbane - July 2017
Four presentations on the subject of medicinal cannabis
- TGA presentations: Updates to good manufacturing practices, 18 July 2017
TGA presentation to industry on phased implementation of PIC/S version 13.0 and update on the soon to be release PIC/S Annex 1
- TGA presentation: Prescription medicines minor variations e-Form: Information sessions, 3 and 5 July 2017
Prescription medicines Minor Variation electronic form
- TGA presentation: Industry presentation, Sydney, 25 May 2017
Provides prescription medicines regulatory affairs personnel with information on development of the new minor variations e-form
- TGA presentation: AusMedtech, 24 May 2017
Outlines reforms to the device regulatory system following the Expert Panel Review of Medicines and Medical Devices Regulation, reforms to the in vitro diagnostic devices (IVD) regulatory framework, reforms to the European and IVD system and the TGA's new Clinical Evidence Guidelines
- TGA presentation: Codeine Industry Forum, 11 May 2017
Provides sponsors of OTC codeine products with information on how to submit an application to change the class of their product to a prescription medicine
- TGA presentation: Immunotherapy@Brisbane, 11 May 2017
Overview of biologicals including the process for inclusion on the Australian Register of Therapeutic Goods, and the regulation of clinical trials in Australia.
- TGA presentation: Royal Australian College of Physicians (RACP) Congress, 9 May 2017
Legislative framework and Commonwealth access schemes relevant to supply of medicinal cannabis
- TGA presentation: Coordinating Office for Clinical Trial Research Annual Workshop, 3 May 2017
Demonstrates the process for submitting an online Clinical Trial Notification (CTN) form
- TGA presentations: International Regulatory Convergence for MTP GMP, April 2017
Three presentations on the subject of Good Manufacturing Practice.
- TGA presentation: ARCS Webinar, 28 April 2017
Overview of recommendations from the Review of Medicines and Medical Devices Regulation relating to low risk therapeutic goods
- TGA presentations: ARCS Webinar, 26 April 2017
Strengthening monitoring of medicines in Australia, provisional approval pathway
- TGA presentation: Australasian Society of Biomaterials and Tissue Engineering (ASBTE) Conference, 18 April 2017
Update on post-market reviews of medical devices
- TGA presentations: CMA Complementary Medicines Regulatory Obligations Seminar, 11 April 2017
Overview, new pathway for complementary medicines, incentives for complementary medicines, permitted indications, regulatory reforms
- TGA presentation: Digital Health Show, 30 March 2017
Explores the definition of a medical device and how this applies to software
- TGA presentations: RACI Supply and Use of Medicinal Cannabis Seminar, 28 March 2017
Medicinal cannabis regulation in Australia
- TGA presentation: Medicinal Cannabis Health Symposium, 23 March 2017
- TGA presentation: Association for Research in Vision and Ophthalmology Asia Conference, 8 February 2017
Overview of the TGA's evaluation process of high-risk opthalmic devices
- TGA presentation: ARCS Seminar, Sydney, 24 January 2017
Local perspective on recent developments in the medical technology and pharmaceutical landscape, and the future of the TGA in a global context
- TGA presentation: ARCS webinar, 17 February 2017 Overview of the reform initiatives relevant to complementary medicines
- TGA presentation: ARCS Webinar, 13 December 2016
Overview of several reform initiatives relevant to prescription medicines