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Validity : 24th Mar'24 to 03rd Apr'24
Risk management is becoming increasingly important for running clinical trials. There are now numerous pharmaceutical guidelines covering risk assessment and management and Risk-Based Monitoring (RBM) including the revised ICH GCP R2 guideline, EU Clinical Trial Regulation guideline, several other risk management clinical research standards and initiatives. In addition, the recent FDA’s guidance on RBM which proposes increased requirements implementation and documentation for RBM.
This essential web seminar will explain the importance of using risk management techniques including RBM in clinical research to comply with the latest focus on GCP inspection in this area including the new RBM FDA guideline. It will show you how risk management including RBM can improve the quality of your clinical trials and demonstrate the importance of using RBM, risk analysis and risk management techniques in clinical trials. You will learn how to identify, evaluate and also how to implement specific risk-based techniques for risk management used in clinical trials. Provides guidance on the latest FDA thinking for RBM. The seminar will provide recommendations on planning RBM, content of a monitoring plan, and addressing and communicating monitoring results to meet FDA and EU inspectors’ expectations.
Anyone working on clinical trials including: