2018 European Union Good Clinical Practice Inspectors Working Group workshop
EventHumanClinical trialsData on medicines
Date
- Tuesday, 9 October 2018, 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.
This year’s workshop will focus on:
- risk proportionate approaches in clinical trials;
- GCP inspections at the sponsor site;
- clinical and statistical evaluation of trial data;
- safety reporting in clinical trials;
- electronic media used in clinical trials.
Please see the programme for further details.
The workshop incorporates 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.