TGA presentations given at the ARCS Congress, 27-28 September 2012
29 November 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.**
The annual ARCS Scientific Congress was held in Canberra on 27-28 September 2012.
The Congress featured over 80 speakers over 6 streams, and a total of 30 sessions.
This year's Congress was aimed at those working in Regulatory Affairs (prescriptions and non-prescriptions) health economics (medicines and devices) and quality GMP.
TGA medicine labelling and packaging review
27 September 2012
Presentation: TGA medicine labelling and packaging review (pdf,486kb)
- Presentation by: Rebecca Doolan, Project Manager, Labelling and Packaging Review, Market Authorisation Group, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: The request from consumers, prescribers, and academics is to reduce the number of avoidable medication errors that are directly caused by inadequate manufacturers labelling and packaging. Is this an achievable goal and what are the multi factorial causes of medication error? Where do we start and where to next i.e. dispensing labelling practices?
Immunogenicity of therapeutic peptides/proteins
27 September 2012
Presentation: Immunogenicity of therapeutic peptides/proteins (pdf,125kb)
- Presentation by: Dr Nena Waight-Sharma, Director, Toxicology, Office of Scientific Evaluation, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: The presentation aims to demonstrate the potential for, and causes of, unwanted immunogenicity of therapeutics including proteins/peptides and non-biologic complex drugs.
Inspection and validation in an increasingly global environment
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27 September 2012
Presentation: Inspection and validation in an increasingly global environment (pdf,1.08Mb)*
- Presentation by: Andrew Giles, GMP Auditor, Office of Manufacturing Quality, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: This session will look at the impact of recently published regulatory and industry guidance as well as provide insight into the statistical tools that can be used to analyse and provide evidence of validation of equipment and processes.
Risk Management Plans - TGA perspective
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27 September 2012
Presentation: Risk Management Plans - TGA perspective (pdf,631kb)*
- Presentation by: Dr Jane Cook, Head, Office of Product Review, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: Hear from the TGA about their expectations regarding RMPs in Australia, their experience to date and proposed streamlining of the RMP process. Industry speakers will provide their perspective on preparing RMPs for Australia and their experience of negotiating RMPs as part of the streamlined submission process.
TGA: update and future directions
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27 September 2012
Presentation: TGA: update and future directions (pdf,512kb)*
- Presentation by: Dr John Skerritt, National Manager, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: Dr John Skerritt, the new TGA National Manager, speaks to ARCS members for the first time on both the progress of reforms and the future direction of the TGA.
TGA Prescription Medicines Streamlined Submission Process
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28 September 2012
Presentation: TGA Prescription Medicines Streamlined Submission Process (pdf,574kb)*
- Presentation by: Dr Felicity Jameson, Director, Evaluation Management, Office of Medicines Authorisation, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: The session will investigate the effectiveness and robustness of the new Streamlined Submission Process to date and explore opportunities to build on and improve this process.
IMDRF
28 September 2012
Presentation: IMDRF (pdf,457kb)
- Presentation by: Dr Larry Kelly, Chair, IMDRF Management Committee
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: Dr Larry Kelly, chair of the IMDRF and European IMDRF representatives to speak on the very latest on international device regulation.
TGA labelling and packaging - complementary medicines
28 September 2012
Presentation: TGA labelling and packaging - complementary medicines (pdf,363kb)
- Presentation by: Trisha Garrett, Acting Head, Office of Complementary Medicines, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: In this critical update for everyone associated with non-prescription medicines you will hear the industry, pharmacist and consumer perspectives on the new packaging and labelling requirements for non-prescription medicines.
Shortages of medicines - the TGA role
28 September 2012
Presentation: Shortages of medicines - the TGA role (pdf,115kb)
- Presentation by: Dr Tony Gill, Acting Principal Medical Adviser, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: What can be and needs to be done to assist in securing the supply chain in multiple situations such as: single source suppliers, natural disasters that interrupt delivery (national and/or international), pandemic or other major health crises.
OTC medicines - business process review
28 September 2012
Presentation: OTC medicines - business process review (pdf,338kb)
- Presentation by: Paul Coronel, Market Authorisation Group, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: This session will begin with an update on the status of the BPR for OTC medicines. This will be followed with the evaluators' perspective looking at the common deficiencies observed in non-prescription regulatory applications.
Medical device conformity assessment explained
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28 September 2012
Presentation: Medical device conformity assessment explained (pdf,2.43Mb)*
- Presentation by: Mr Gary Burgess, Director, Devices Conformity Assessment Section, Office of Devices Authorisation, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: This session will explain key concepts, the reason behind them, the meaning of the different Parts or Annexes and how they are applied to choose the correct path for successful registration of medical devices and the common pitfalls that cause rejection as well the general submission requirements for class III medical devices.
The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
28 September 2012
- Presentation by: Roger Feltham, Assistant Director, Prescription Medicines Clinical Unit 3, Office of Medicines Authorisation, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: This session is intended to show that the fate of naturally-derived products depends on identifying early on, not only commercial feasibility, but also the regulatory hurdles associated with the desired claims and indications.
The changing face of manufacturing quality
28 September 2012
Presentation: The changing face of manufacturing quality (pdf,129kb)
- Presentation by: Bill Turner, Head, Office of Manufacturing Quality, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: This session provided an update on international activities to enhance cooperation on regulatory inspections.
Australia New Zealand Therapeutic Products Agency (ANZTPA)
28 September 2012
Presentation: Australia New Zealand Therapeutic Products Agency (ANZTPA) (pdf,73kb)
- Presentation by: Margaret Lyons, ANZTPA, TGA
- Presented at: ARCS Congress, 27-28 September 2012, Canberra
- Presentation summary: This session provided an overview of the program of work being undertaken to progress the implementation of a joint Australia and New Zealand scheme for the regulation of therapeutic products. The presentation included detail on the phased implementation approach and the business to business projects currently underway.
Content last updated: Thursday, 29 November 2012
Content last reviewed: Thursday, 29 November 2012
Web page last updated: Thursday, 29 November 2012
URL: http://www.tga.gov.au/newsroom/events-presentations-arcs-1209.htm