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edma - european diagnostic manufacturers association, eucomed, ghtf (global harmonization task force), harmonization of standards
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  #1  
Old 16th May 2011, 04:04 AM
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Question GHTF's (Global Harmonization Task Force) Latest

Has anyone got the latest news about GHTF?

I got the following from Eucomed, but not sure what it exactly means/imply, so GHTF is going to stay more or less the same?

-------------------------------------------------
GHTF: Regulators, medical technology and in vitro diagnostic industry commit to future together
Real opportunity for regulators and industry to participate in future forum
Brussels, 16 May 2011 – EDMA, the European Diagnostic Manufacturers Association, and Eucomed, the European medical technology industry association, welcome the outcomes of the constructive discussions that took place at the last GHTF Steering Committee meeting held on 11-13 May in Brisbane, Australia. Both regulators and industry have confirmed their commitment to continuing to collaborate on the development of robust, globally consistent regulatory systems which facilitate access to innovative, safe, effective and high quality, clinically beneficial medical technologies for the benefit of patients around the world.

During the three-day summit, it became apparent that GHTF members appreciated the work of the GHTF Steering Committee over the past decades. There has also been a useful exchange of views on desirable elements of future forum. The Steering Committee also confirmed the review of the existing Study Group Works Plans and progressed on planned work. An overall consensus was reached on the necessity of enhancing international harmonisation, which was seen as a critical part in maintaining public health.

Philippe Jacon, EDMA ad interim Director General, commented: “I am particularly pleased with the outcomes of the GHTF Steering Committee as the planned work was taken further, and the support for existing GHTF guidance was reaffirmed”.

John Wilkinson, Eucomed Chief Executive, added: “There is a real opportunity for regulators and industry to participate in the new direction this forum will take and I believe that all the members of the Steering Committee can be congratulated for the work they have done over the past decades. We look forward to continuing to work with all the members of the GHTF towards harmonised regulations which will enhance public health”.

Both EDMA and Eucomed fully support the work done by the GHTF and will remain active partners in the work of the future GHTF.

The transition planning by regulators and industry is underway.

About Eucomed
Eucomed is the European medical technology industry association. Its mission is to improve patient and clinician access to modern, innovative and reliable medical technology. Eucomed represents directly and indirectly 22,500 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. Small and medium sized companies make up more than 80% of this sector. The European medical technology industry generates annual sales of €95 billion, invests some €7.5 billion in R&D and employs around 500,000 highly skilled workers. For more information visit www.eucomed.org

About EDMA
EDMA, the European Diagnostic Manufacturers Association, represents national trade associations and major companies engaged in the research, development, manufacture or distribution of In Vitro Diagnostic (IVD) medical devices in Europe. Through its affiliated associations, EDMA represents more than 500 companies across Europe. The mission of EDMA is to raise awareness of the importance and added value diagnostic information provides to healthcare. EDMA cooperates with European institutions, patients groups, trade associations, health professionals and academia to support an appropriate regulatory system, to work towards a realistic economic environment for healthcare and to be an effective voice in globalisation.
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  #2  
Old 16th May 2011, 04:53 AM
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Re: GHTF's (Global Harmonization Task Force) Latest

I think it will be industry driven minus the big regulators like US FDA

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Old 18th May 2011, 10:10 PM
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Re: GHTF's (Global Harmonization Task Force) Latest

Got the following from Medtechinsider, so it seems that's it. (http://medtechinsider.com/archives/22900)



----------------------------------
Steering Committee of the Global Harmonisation Task Force Holds Final Meeting
May 16, 2011 – 3:51 pm
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The Steering Committee of the Global Harmonisation Task Force met for the final time on 11-13 May in Brisbane, Australia. EDMA, the European Diagnostic Manufacturers Association, and Eucomed, the European medical technology industry association, said that they were pleased with the outcome of the committee’s work during the past decades, according to a Eucomed press release. Both organisations have pledged to remain active partners with GHTF in the future.

The Steering Committee confirmed the review of the existing Study Group work plans and progressed on planned work. Both regulators and industry have confirmed their commitment to continuing to collaborate on the development of robust, globally consistent regulatory systems.

The Global Harmonization Task Force launched in 1992 with the purpose of working towards international harmonisation in the regulation of medical devices. The Steering Committee was established to “provide policy direction, strategic planning, and to assign and provide oversight of technical work initiatives”, according to the Global Harmonization Task Force website. It first met in 2001.

Camilla Andersson

Tags: EDMA, Eucomed, European Diagnostic Manufacturers Association, GHTF, Global Harmonisation Task Force
Thank You to pseudoazurin for your informative Post and/or Attachment!
  #4  
Old 19th May 2011, 04:48 AM
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Re: GHTF's (Global Harmonization Task Force) Latest

Quote:
In Reply to Parent Post by pseudoazurin View Post

Got the following from Medtechinsider, so it seems that's it. (http://medtechinsider.com/archives/22900)



----------------------------------
Steering Committee of the Global Harmonisation Task Force Holds Final Meeting
May 16, 2011 – 3:51 pm
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The Steering Committee of the Global Harmonisation Task Force met for the final time on 11-13 May in Brisbane, Australia. EDMA, the European Diagnostic Manufacturers Association, and Eucomed, the European medical technology industry association, said that they were pleased with the outcome of the committee’s work during the past decades, according to a Eucomed press release. Both organisations have pledged to remain active partners with GHTF in the future.

The Steering Committee confirmed the review of the existing Study Group work plans and progressed on planned work. Both regulators and industry have confirmed their commitment to continuing to collaborate on the development of robust, globally consistent regulatory systems.

The Global Harmonization Task Force launched in 1992 with the purpose of working towards international harmonisation in the regulation of medical devices. The Steering Committee was established to “provide policy direction, strategic planning, and to assign and provide oversight of technical work initiatives”, according to the Global Harmonization Task Force website. It first met in 2001.

Camilla Andersson

Tags: EDMA, Eucomed, European Diagnostic Manufacturers Association, GHTF, Global Harmonisation Task Force
Ajit / Pseudo,

Forgive me for being so thick, but did you get your conclusions from the quoted text or do you have other sources / perspectives that provide those insights? I'm asking because to me the text is everything BUT clear and definitive. Is there some subtle subtext I'm missing?... All I could figure out was that industry was frustrated with the regulators initial intentions (which we already knew), and that regulators are now less determined to exclude industry from the future forum. It felt as if we'll only hear the last word from the regulators in the future. So please, could you shed some more light for slow guys like me?...

Thanks,
Ronen.
  #5  
Old 19th May 2011, 05:20 AM
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Re: GHTF's (Global Harmonization Task Force) Latest

Hi Ronen,

You are definiteky not slow

Even I am surprised over the GHTF activities as to why nothing concrete is coming out in the open. Neither the GHTF website nor the regulator website give info clearly.

I think we have to wait patiently for some more time

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  #6  
Old 19th May 2011, 05:55 PM
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Re: GHTF's (Global Harmonization Task Force) Latest

I am starting to wonder what the GHTF is all about.

Surely considering it's been set up since 1992, a greater impact should have been achieved to date.
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