Department to fund Codes of Conduct initiative

The Government has decided to fund the ongoinging harmonisation of therapeutic goods sector Codes of Conduct in a surprise move in the 2012 Budget. Through 2012-16, the Government will provide $1.4 million to assist industry to develop strong, consistent and enforceable codes of conduct based on a common framework of high level principles, and shared mechanisms for communication and complaints handling, as set out by the Trimmer Committee. At this stage it appears that the money, spread over 4 years, will mainly be used on Departmental expenses.

National Bowel Cancer Screening Program extended

The Government has decided to extend the National Bowel Cancer Screening program in the 2012 -13 Budget to provide for additional screening for people aged 60 and 70 at a cost of about $50 million. This means that the program will now cover all Australians aged 50, 55, 60, 65 and 70 by 2015. It will be further extended in 2017-18 to cover all Australians every 2 years. Read the Press Release here

TGA National Manager

Dr John Skerritt has been appointed as TGA National Manager following a recruitment campaign after the departure of Dr Rohan Hammett to NSW Health. Dr Skerritt, who has a background in pharmacology and medical research, has been most recently the Deputy Secretary of the Victorian Department of Primary Industry. He has a degree in Finance and Management from the London Business School. IVD Australia has welcomed his appointment and looks forward to his contribution to the IVD Transition Period which is now close to its mid-point. Read our Press Release here.

Response to TGA increase fees and charges

The major news over the last month has been the proposal by the TGA to increase fees for the 2012/13 year by up to 5.6%. This would incorporate a 3.6% increase attributed to cost increases within the TGA (principally salary increases) plus an up to 2% increase in order to implement the TGA reforms outlined by the Parliamentary Secretary.

Not unexpectedly, all health sector industry associations, including IVD Australia, have strongly opposed this increase. The Medical Device associations (IVD Australia, MTAA, ADIA and AusBiotech) have written to the TGA setting out our oppositions on a number of grounds. Read the response here

TGA Sponsor information Day- Canberra

In conjunction with IVD Australia, MTAA, ADIA and AusBiotech, the TGA are pleased to present an Information and Training event especially for sponsors and manufacturers of medical devices and in vitro diagnostic medical devices.

Speakers from the TGA will be addressing topics identified by the industry associations and the TGA that have practical applications to help companies improve their everyday business dealings with the regulator. Sessions will cover a wide range of regulatory issues relating to submitting applications, post marketing surveillance and adverse event reporting.

Don't miss this opportunity to get the answers to those challenging questions from the TGA experts.

When:         22 June 2012 l  9:30am- 4:30pm

Where:        Old Parliament House

                      18 King George Terrace  Parkes ACT

Cost:            $275 incl GST

Flyer:            Download the flyer and the program

Register:      Click here to register

Questions:   info@ivd.org.au

Conformity Assessment Workshop- Melbourne

This new workshop, developed by IVD Australia and Stellar Consulting provides in-depth training for the successful completion of the Conformity Assessments process as required by the TGA for higher risk IVDs. This advanced workshop is aimed at persons who have completed the IVD technical and regulatory training and all senior regulatory staff.

When:         20 July 2012

Where:        Beau Monde International

                      934 Doncaster Road, Doncaster East, Victoria, 3109

Cost:            $350 incl GST members

                     $525 incl GST  non members

Flyer:            Download the flyer

Register:      Click here to register

Questions:   info@ivd.org.au

Industry Events

ARCS Sydney 2012 Scientific Conference

06 -07 June 2012, Sydney Convention Centre, Darling Harbour, NSW

The 2012 ARCS Annual Scientific Congress returns in 2012 to the Darling Harbour Convention Centre on 6th and 7th June.  

Abstracts for the meeting have been called for by the Organising Committee and Guidelines are available from the website.

The preliminary details on the Congress can be found here

 

29th Annual NRL workshop on Infectious Diseases

 31 July- 3 August 2012, Park Hyatt Hotel, Melbourne, NSW

The Annual NRL Workshop on Infectious Diseases is a unique and premier event that brings together scientists, laboratory managers, pathologists, clinicians, regulators, test kit manufacturers and sponsors working in the field of Infectious Diseases.

The NRL Workshop provides an excellent opportunity for all involved in the field of infectious diseases to network and establish collaborative relationships. We look forward to welcoming all delegates to Melbourne for the 29th Annual NRL Workshop on Infectious Diseases. Melbourne is a dynamic and cosmopolitan city with surprises to be discovered in every basement, rooftop and laneway. Food and wine, art, music and sport – Melbourne offers something for everyone.