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TGA and industry presentations - Devices Sponsor Information Day, 9 September 2014
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The Sponsor Information & Training Day Program (pdf, 637KB) indicates 15 sessions, of which 13 sessions have presentations listed below (the last two panel discussion sessions do not have presentations). The presentations consist of content prepared and presented by representatives of industry and representatives of TGA. The TGA content is on pages (slides) marked as Department of Health Therapeutic Goods Administration. The presentations vary in format. The introductory Plenary is presented by Prof John Skerritt, National Manager, TGA. The other 12 sessions listed below are combined presentations with sections or components by TGA and Industry (reflecting how they were presented on the day). The listing of the presentations below reflects the thematic streams (medical devices - Sessions A and B, and IVDs - Session C).
Sessions
- Plenary: Role of TGA
- Session A1: Medical Devices - Efficient medical device applications
- Session A2 - Medical Devices Changes (I) Devices that have undergone TGA Conformity Assessment
- Session A3: Medical Devices Post-market vigilance activities
- Session A4: Medical Devices Recall and non-recall actions of medical devices
- Session B1: Medical Devices Conformity assessment
- Session B2: Medical Devices Accurate manufacturers evidence
- Session B3: Medical Devices Advertising
- Session B4: Medical Devices Decision making and reviews
- Session C1: IVDs eBS applications and the application process
- Session C2: IVDs Application audits (technical file reviews)
- Session C3: IVDs Post-market responsibilities (I)
- Session C4: IVDs Post-market responsibilities (II)
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation slides should not be relied upon in any way as representing a comprehensive description of regulatory requirements, (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers (slides), and (c) the industry slides (on the green Sponsor Information & Training Day templates) are the views of the listed speaker, and are not endorsed by TGA. They have been included here for the convenience of attendees and other interested in the content of the event, in the interest of completeness.