2017 European Union Good Clinical Practice Inspectors Working Group workshop
EventCorporate
Date
- Tuesday, 3 October 2017, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
This workshop is for good clinical practice (GCP) inspectors of European Union (EU) and European Economic Area (EEA) Member States as well as inspectors from non-EU countries. It consists of presentations, discussions and 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 focuses on sponsor site inspections (covering centralised monitoring and computer system validation), difficulties when performing un-announced GCP inspections, patient reported outcome (PRO)/e-PRO and things 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 and assessors' perspectives, inspections of oncology trials and GCP international collaboration.