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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 20:12:20
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 Subject :EFGCP–EUCROF Joint Workshop Final Report .. 2010-08-20 20:12:20 
GCP HelpDesk
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Joined: 2009-06-18 15:31:58
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Dear Friends,

Please find attached Report: "ETHICAL CHALLENGES IN CLINICAL RESEARCH AT BOTH ENDS OF LIFE" of the EFGCP–EUCROF Joint Workshop on Common Lessons to be Learnt from Paediatric and Geriatric Clinical Development held at the Crowne Plaza, Antwerp, Belgium 27 and 28 April 2010.

Kind regards,



Attachments
 Final Report.pdf [244 KB] ::
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