EMA co-ordinated GCP and BE inspections online training course

A series of narrated presentations, videos and supplementary material, designed and delivered by members of the GCP/BE Inspectors curriculum steering group, including the EMA Inspections Office and the GCP IWG.

Topics: Overview of EMA inspection coordination process; Preparation and conduct of investigator site inspections, sponsor site inspections, and BE inspection; Reporting inspections – writing of Inspection Report and Integrated Inspection Report 

Target audience: This training is aimed at EU GCP inspectors who are in the process of training to support and lead inspections coordinated by EMA. 

Difficulty level: competent / advanced.

Duration: 9 hours

Link for NCAs

Link for EMA

For more information on the EU NTC, please see EU NTC portal