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Global Harmonisation Task Force: guidance on electronic vigilance reporting one of latest postings

This article was originally published in Clinica

Executive Summary

Guidance on electronic vigilance reporting has been prepared by Study Group 2 of the Global Harmonization Task Force, responsible for developing guidance documents for medical device vigilance, and posted on the GHTF website as a proposed document. The guidance has been presented as working files that will form the basis of a pilot project conducted by SG2 on electronic reporting. Referred to as N87R7, it is described as a ZIP guidance document bundle and contains a spreadsheet file that summarises the SML data structure being considered. GHTF is inviting public comment, which will be considered alongside the results of the pilot project before the document progresses to final status.

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