2016 European Union Good Clinical Practice Inspectors Working Group workshop
EventCorporateCompliance and inspections
Date
- Monday, 17 October 2016, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
A total of 120 GCP inspectors of EU/EEA Member States as well as delegates from non-EU countries are registered to take part in the 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: GCP inspections of ATMPs, oncology trials (covering both inspectors' and assessors' perspectives), optimisation of writing inspection findings, topics of interest discussed at GCP IWG meetings and EU and international perspectives on inspection findings impact and grading.