Course description
This practical course provides an in-depth understanding of current and planned GCP requirements and their practical implications as well as insights into the current GCP inspection focus and hot topics.
The course will discuss the forthcoming changes in ICH GCP (E6 Revision 3) and their impact as well as the implementation of ICH E8 R1 covering Quality by Design principles.
The course will bring clarifications on risk-based approaches used in clinical trials, and how to implement acceptable risk management tools. We will also touch base on the changes required following the implementation of the EMA Guideline on computerized systems and electronic data in clinical trials.
We will discuss how to fulfil sponsor oversight expectation and you will learn how to achieve proven inspection readiness. Samples of inspection observations will also be shared.
