Course description
This practical course provides an in-depth understanding of the latest GCP requirements and its practical implications as well as insights into the current GCP inspection focus and hot topics.
The course will bring clarifications on risk-based approaches used in clinical trials, how to set up risk based audits (including remote and hybrid audits) and how to achieve appropriate risk based monitoring. You will learn about regulatory inspection results, views on eTMF inspection readiness and sponsor oversight, and you will discuss Data integrity challenges.
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