Good Clinical Practice ICH E8 (R1) for Clinical Research
What you'll learn
- Understand the General Quality Principles of Clinical Research
- Understand why a revision to the original E8 was needed
- Understand the link between ICH E8 and ICH-Good Clinical Practice (GCP) E6 (R3)
- Learn how to identify Critical to Quality (CtQ) factors
- Identify and understand the ICH E8 requirements for optimal design and conduct clinical studies
- Learn and understand how to apply 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 case studies where Quality-by-Design (QbD) was implemented Vs not implemented
- This course is dedicated to all professionals willing to learn how to design quality into their clinical studies
Expert advices on how to promote Quality Culture and Best Practices to Design Quality into your Clinical Studies!
This course presents the key concepts outlined in already approved umbrella guideline ICH E8 (R1), serving as the foundation to update ICH GCP E6 (R3), and is therefore part of the mandatory GCP training. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.
This course provides an overall 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. This course complements well the GCP principles that all clinical research professionals must follow.
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!
Who this course is for:
- This course is intended to all professionals involved in the design and conduct of clinical studies across the product lifecycle, such as clinical development & operations personnel.
Vincent Baeyens, PharmD, PhD is a recognized expert with over 25 years’ global R&D and clinical operations leadership experience in Clinical Research.
He served as executive leader in several Global Pharma's and Biotech settings. He conducted Clinical Trials globally in Europe, US, India, Japan and Latin America.
Vincent holds a master’s degree in Pharmacy, from the University of Louvain in Belgium, and a PhD in Pharmaceutical Science, from the University of Geneva, Switzerland.