General Principles ICH E8 (R1) for Clinical Studies

Updated in July 2025 to align with ICH-GCP R3

This Good Clinical Practice (GCP) course is aimed at bringing your GCP knowledge to the next level by Proactively Designing and Implementing Quality into your daily life in Clinical Trials and Drug Development

ICH E8 (R1) serves as the foundation guideline of ICH GCP E6 (R3), and is therefore part of the mandatory GCP training.

This course provides a practical introduction to clinical development, with a focus on designing quality into clinical trials and identifying critical factors that impact the quality of the trials in order to facilitate acceptance of data and results by regulatory authorities worldwide.

We will emphasize the importance of considering quality throughout the clinical trial lifecycle, from study design and planning to conduct, analysis, and reporting. It highlights the need to manage risks that may impact the safety of study participants and the reliability of trial data, and provides guidance how to do so.

During this course, you will learn to implement the quality by design (QbD) concept in the design, planning, conduct and reporting of your clinical trials. This course will help focus on what really matters in order to ensure the protection of study participants, the integrity of the data and reliability and the ability of the studies to meet their objectives..

I designed this course based on my 20+ experience in drug development for any clinical research professional seeking to learn how to design quality in their clinical studies and anticipate problems that may occur.

Together, I will walk you through the QbD concepts , so that you will be able to apply QbD to your daily practice.

We will :

• Understand the General Quality Principles of Clinical Research

• Understand the link between ICH E8 (R1) and ICH GCP E6

• Learn how to identify Critical to Quality factors

• Identify and understand the ICH E8 (R1) requirements for optimal design and conduct clinical studies

• Understand and learn how to apply practically the process to implement good design quality into clinical studies

• Learn how to utilize good study design practice to optimize drug development planning

• Understand the key elements of the study protocol that may be used to optimize the design of a study

• Learn from the experience in real case studies where QbD was implemented Vs not implemented

This course is dedicated to all clinical research professionals willing to learn how to design quality into their clinical studies in line with the ICH GCP principles.

To facilitate the learning experience, the course has been broken up on purpose in several small lectures. If you are a more advanced student, you can increase the speed of lecture to learn the course at your own pace.

A final Practice Test at the end of the course will consolidate your knowledge.

Feel free to look at the content of the course to know more and contact me any time if you have any questions!

Are you ready?

I am looking forward to seeing you inside this course!

Sincerely,

Vincent