Recent publications by FDA on risk-based monitoring and EMA's guidance in risk-based quality management in clinical trials and the current discussions at Clinical Trial Transformation Initiative (CTTI) will have a major influence on how clinical studies will be designed and conducted in the future. Regulators have issued guidances that discuss and describe how an approach to future quality management in clinical studies should look like. The implications for clinical trials will be discussed by a Sponsor and a CRO representative. Developed by the Quality Risk Management (QRM) SIAC.

Learning Objectives:
Discuss how the new publications by FDA and EMA will influence clinical trials in the future from both pharmaceutical industry and CRO perspective.