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How should HTA methods be adapted to meet the rising expectations of decision makers for medical devices and diagnostics reimbursement ? Issue Panel – ISPOR 12th Annual European CongressOctober 27th, 200910-11 am Moderator• Annie CHICOYE, expert to IMS Pricing and Market Access EU Panelists• Geoffroy WILSON, Reimbursement Leader, GE Healthcare, EMEA • Adrian GRIFFIN, VP Strategic Affairs, LifeScan EMEA • Pr Olivier GOEAU-BRISSONNIERE – Chairman of the Fédération des Spécialités Médicales, ex member of the medical devices HTA commission at the HAS • 2Medical devices and diagnostics : a wide range of health care products …Medical devices In Vitro diagnostics (directive 2007/47/EC) (directive 98/79/EC)« any instrument, apparatus, “Any medical device which is a appliance, software, material or reagent, reagent product, calibrator, other article, whether used control material, kit, instrument, alone or in combination, apparatus, equipment, or system, whether used alone or in including the software intended by combination, intended by the its manufacturer to be used manufacturer to be used in vitro for specifically for diagnostics and / or the examination of specimens, therapeutics purposes and including blood and tissue donations, necessary for its proper derived from the human body, solely or application, intended by the principally for the purpose of manufacturer to be used for providing information: concerning a human beings for the ...
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