TGA presentations given at the ATBF, 29 May 2012
5 July 2012
**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 and Ageing (of which the TGA is a division) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers.**
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ARTG inclusion for biologicals
29 May 2012
Presentation: ARTG inclusion for biologicals (pdf,464kb)
- Presented by: Tony Manderson, Biological Science Section, Office of Scientific Evaluation, TGA
- Presented at: Australasian Tissue and Biotherapeutics Forum, and Asia Pacific Association of Surgical Tissue Banking, and International Society of Cellular Therapy (Australasian Chapter) combined Scientific Meeting, 29 May 2012
- Summary of presentation: This presentation provide a guide to making an application for ARTG inclusion for a biological.
Clinical trials in a changing regulatory environment
29 May 2012
Presentation: Clinical trials in a changing regulatory environment (pdf,743)
- Presented by: Dr Tony Gill, Director, Experimental Products Section, Office of Scientific Evaluation, Market Authorisation Group, TGA
- Presented at: Australian Tissue and Biotherapeutics Forum (ATBF), 29 May 2012
- Summary of presentation: This presentation is on clinical trials in a changing regulatory environment.
Good manufacturing practice: A snapshot of GMP in the cellular therapy and tissue sectors
29 May 2012
- Presented by: Katherine Clark, GMP Auditor, Office of Manufacturing Quality, TGA
- Presented at: Australasian Tissue & Biotherapeutics Forum (ATBF) Scientific Meeting, 28 May - 1 June 2012
- Summary of presentation: This presentation provides a snapshot of the common deficiencies raised in the cell and tissue audit program and compares the current GMP Code with the proposed draft GMP Code. Upcoming developments with regards to GMP are also presented.
Implementation of the new biologicals framework in Australia
29 May 2012
Presentation: Implementation of the new biologicals framework in Australia (pdf,792kb)
- Presented by: Loretta Huckstepp, Biological Science Section, Office of Scientific Evaluation, TGA
- Presented at: Australasian Tissue and Biotherapeutics Forum, and Asia Pacific Association of Surgical Tissue Banking, and International Society of Cellular Therapy (Australasian Chapter) combined Scientific Meeting, 29 May 2012
- Summary of presentation: This presentation provided an update on the implementation of the biologicals regulatory framework
Content last updated: Thursday, 5 July 2012
Content last reviewed: Thursday, 5 July 2012
Web page last updated: Thursday, 5 July 2012
URL: http://www.tga.gov.au/newsroom/events-presentations-atbf-120529.htm