pseudoazurin
Involved In Discussions
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?
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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.
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.
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?...
