2017 European Union Good Clinical Practice Inspectors Working Group workshop

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Title2017 European Union Good Clinical Practice Inspectors Working Group workshop
Date03/10/2017 - 05/10/2017
LocationContinental Hotel, Budapest, Hungary
SummaryGood Clinical Practice (GCP) inspectors of European Union (EU) / European Economic Area (EEA) Member States as well as inspectors from non-EU countries will be taking part in this workshop. The workshop will consist of presentations, discussions as well as a number of breakout sessions during which participants will be given case studies and examples of inspection findings to discuss and analyse within their group. This year’s workshop will focus on the following topics: sponsor site inspections (covering centralized monitoring and computer system validation), difficulties when performing un-announced GCP inspections, patient reported outcome (PRO)/e-PRO: what to consider during a GCP inspection, GCP inspections of phase I units, updates on the Clinical Trials Regulation no. 536/2014, GCP inspections of biosimilars (assessors’ perspectives), inspections of oncology trials and GCP international collaboration.

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Name Language First published Last updated
Agenda - 2017 European Union Good Clinical Practice Inspectors Working Group workshop (English only) 2017-09-25  

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