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Pulseline

10th January 2018

What's New?

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Save the Date -  MTAA 2018 Annual Conference

The next MedTech Annual Conference will be held:

 

DATE:     7th & 8th November 2018

VENUE:  Luna Park Sydney


Mark the dates in your diary to attend the MedTech industry event of the year!

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New Digital Platform to launch this year

MTAA is developing a digital platform as part of an initiative to better engage with industry, government and the public. A key component of the digital platform will be the production and distribution of industry positive insights, news and information.

 

If you have any questions, would like to know more or would like to contribute please contact polo@mtaa.org.au

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2018 Introduction to Operating Theatre Protocols courses

New Introduction to Operating Theatre Protocols courses have been announced for Sydney, Melbourne & Brisbane for 2018.  Get ahead of the queue and book early!


1.5 Introduction to Operating Theatre Protocols (9th February, 2018) Melbourne
1.5 Introduction to Operating Theatre Protocols (23rd February, 2018) Sydney
1.5 Introduction to Operating Theatre Protocols (27th February 2018) Brisbane
1.5 Introduction to Operating Theatre Protocols (23rd March, 2018) Sydney

1.5 Introduction to Operating Theatre Protocols (10th April, 2018) Melbourne

 

More face-to-face and online courses are available via the Training Module Library


Please email pd@mtaa.org.au for booking assistance or contact the MTAA Professional Development Manager Lee Grow - lgrow@mtaa.org.au for more information.

Industry News

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Medical Technology Industry supports calls for Increased Transparency

The Medical Technology Association of Australia (MTAA) has welcomed the Senate Community Affairs inquiry recommendations into the value and affordability of private health insurance and out-of-pocket medical costs.

 

Transparency was a clear theme among the 19 recommendations made by the Committee.

 

Some of those recommendations were the direct result of the evidence from MTAA, including calling on the Government to ask the Australian National Audit Office (ANAO) to report in 12 months on whether the benefits from the Prostheses List reforms are being passed on to consumers.

 

MTAA outlined several opportunities during the inquiries to improve the value of private health insurance including the use of medical technology to facilitate innovative healthcare interventions and innovative models of care outside the hospital setting, including telehealth, remote monitoring and home dialysis.

 

The Committee acknowledged several factors were increasing underlying costs for private health insurers, but it also noted the substantial profits that insurers were recording: “To a certain extent that undermines their argument that underlying costs are driving up premiums.”

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Clinical Trials for Medical Devices

MTAA has published an online resource Clinical Trials for Medical Devices – The Basics, developed to help companies and individuals understand the value and purpose of clinical trials specifically for medical devices. 

 

Clinical trials generate the evidence to enable marketing of safe and effective medical devices in Australia. Trials or investigations may also enable clinically and cost-effective interventions and technologies to be assessed and funded.

 

The online resource also highlights the different types of studies a medical device can undertake as well as links to further information and resources pertaining to conducting a study.

MTAA has further spearheaded the development of clinical research agreements for commercially-sponsored studies of medical technology. 

 

Previously, companies had to use a suite of agreements developed primarily for the pharmaceutical industry that was not always suitable to cater to the needs of the medical technology industry. 

 

In 2017 a new standard form agreement "The MTAA Standard Clinical Investigations Research Agreement" was developed in conjunction with the South-Eastern Border States (SEBS) approval authority encompassing the NSW Ministry of Health.

 

The online resource Clinical Trials for Medical Devices - The Basics, as well as the template clinical research agreements for medical devices are available for download from the MTAA website.

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Update on Australian regulatory framework for Medical Devices

On 10 February 2017 MTAA received an invitation from the Community Affairs Legislation Committee to provide a written submission on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016.

 

Here are some of our latest submissions:


MTAA Submission - Therapeutic Goods Advertising Code - Oct 2017
MTAA Response - 3D printing technology in MedTech - Oct 2017
MTAA Submission - Proposed regulatory changes to personalised 3D printed medical devices - Dec 2017

 

As a reminder, the new Uniform Recall Procedure for Therapeutic Goods (URPTG) will be implemented next Monday, 15 January 2018.

External Opportunities

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Earn your regulatory affairs qualification online in 6-12 months

Developed by industry experts, the University of Wollongong’s Graduate Certificate in Regulatory Science is an online course that will give you the qualification you need as a regulatory affairs specialist.

 

This course, which can be completed in 6 or 12 months, will help you:

  • Build a portfolio of practical experience in navigating regulatory frameworks that you can apply at your firm.
  • Get industry-focused applied course content, delivered by industry experts.
  • Understand how quality management systems can generate competitive advantage for your firm.
  • Get ahead of the potential industry changes to regulations, which may require university qualifications.
     

UOW has government subsidised places available for domestic students studying this course (see Commonwealth Supported Places).

 

Enquire and apply online now, starts 26 February 2018.

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Call for abstracts for the 42nd World Hospital Congress

The Australian Healthcare and Hospitals Association is calling for Abstracts for the 42nd World Hospital Congress to be held in Brisbane in October. Australian and international health sector leaders wishing to present their work, orally or as a poster at the Congress are invited to submit abstracts of no more than 500 words by 15 January 2018, using the online submission form.

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The Bridge Program

Queensland University of Technology, in collaboration with MTPConnect and 15 pharmaceutical companies, universities and industry associations will be delivering an exciting, new and innovative education program that will provide the necessary training to enable the successful commercialisation of Australian pharmaceutical research.

 

The 2018 offering of the program will select participants from across Australia to take part in face-to-face and online training in the scientific, legal, financial, clinical, regulatory and reimbursement disciplines that contribute to research translation and the commercialisation of medicines.

 

Expression of Interest closes on 2 February 2018

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