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Archived presentations 2017
The presentations in this section were given at conferences, workshops and seminars in 2017. The information in these presentations may not be current.
December 2017
- Presentations: Codeine up-scheduling workshops, Wagga Wagga, 14 December 2017
The TGA held a series of workshops on the up-scheduling of codeine - Presentation: Therapeutic Innovation Australia Symposium 2017, 14 December 2017
Introducing SME Assist at the Therapeutic Innovation Australia Symposium 2017 - Presentations: Codeine up-scheduling workshops, Brisbane, 13 December 2017
The TGA held a series of workshops on the up-scheduling of codeine - TGA presentations: Adoption of PIC/S Guide to GMP PE009-13, 13 December 2017
The TGA presented to CAPSIG on the adoption of the PIC/S Guide to GMP PE009-13 - TGA presentation: Wearable Technologies Conference, 7 December 2017
Which devices does the TGA regulate and how do they do it?
November 2017
- Presentations: Codeine up-scheduling workshops, Perth, 30 November 2017
The TGA held a series of workshops on the up-scheduling of codeine - Presentations: Codeine up-scheduling workshops, Melbourne, 28 November 2017
The TGA held a series of workshops on the up-scheduling of codeine - TGA presentation: Adoption of TGO 91 - Prescription medicine labelling, 28 November 2017
ARCS webinar on prescription medicine labelling - 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.
October 2017
- 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.
September 2017
- 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.
August 2017
- TGA presentations: 2017 ARCS Annual Conference, 22-24 August 2017
Presentations from the TGA on a variety of topics - TGA presentation: RACI and CAPSIG societies, 16 August 2017
Overview of the GMP regulations specific to cleaning validation for medicine manufacturers.
July 2017
- 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
May 2017
- 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
April 2017
- 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
March 2017
- 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
Approval pathways
February 2017
- TGA presentation: ARCS webinar, 17 February 2017
Overview of the reform initiatives relevant to complementary medicines - 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
January 2017
- 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