Language: English


Key objectives:


  1. To provide an overview of the history of GCP
  2. To understand the key principles of GCP, including – informed consent, ethics committees, the key roles (sponsor, monitor and investigator), GMP and IMP, safety reporting, and reporting.
  3. To identify and discuss key GCP and Clinical Trial Directive problem areas.


This course includes the R2 revision to the ICH GCP guidelines.


Apply HERE