Risk management in clinical trials is playing an increasingly important role and with ICH GCP E6 (R2) it is becoming the focus of every government ..
inspection. Risk management networks a wide variety of areas and often causes confusion of terms in the field of clinical studies. This webinar aims to provide participants with insights into risk management in relation to processes as well as patient safety. In addition to the theoretical basics, practical examples and the authority's expectations are presented. The webinar conveys step by step the procedure for the identification and assessment of risks according to ICH GCP E6 (R2) but also the procedure for the careful planning of studies to contain and avoid risks. In addition, you will get to know and apply the systematic monitoring of risk indicators with practical examples. Escalation and communication with the relevant interfaces play an important role, which is conveyed using examples.