Course Description

The principles of GCP are designed to be flexible and applicable to a broad range of clinical trials. The updated E6 guideline, along with ICH E8, encourages thoughtful consideration and planning to address specific and potentially unique aspects of an individual clinical trial. This includes evaluation of trial characteristics, such as the design elements, the investigational product being evaluated, the medical condition being addressed, characteristics of the participants, the setting in which the clinical trial is being conducted, and the type of data being collected. Careful consideration of factors relevant to ensuring trial quality, including critical-to-quality (CTQ) factors, are needed for each clinical trial. This web seminar will provide a high-level overview of the drivers and changes planned for implementation.

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Learning Objectives

• Introduce rationale, revisions, and release to ICH E6 (R3)
• Review changes to principles in ICH E6 (R3)
• Introduce rationale, revisions, and release of E8
• Review CTQ factors that should be considered when planning a study
• Demonstrate that ICH E8 provides cross-referencing to other relevant ICH guidelines for planning and executing development program-related studies

Who Should Attend

• Senior Leaders, Directors, and Managers
• Clinical Research Associates
• Clinical Research Coordinators
• Study Managers
• Quality Personnel
• Data Managers
• Business Process Owners

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

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Hold this course at your company! For more information, contact Naila Ganatra at +1