*NEW*General Considerations for Clinical Studies ICH E8 (R1)
Dr. Vincent Baeyens
2:31:00
Description
Key Concept for ICH GCP E6 (R3) - Guideline on Best Practices to Design Quality into Clinical Studies
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
Who is this for?
What You Need to Know?
More details
DescriptionWelcome to this ICH E8(R1) course to design quality into your Clinical Studies !
The ICH E8 (R1) is the umbrella guideline of the ICH family and works hand-in-hand with the ICH E6 Good Clinical Practice (R3) guideline.
This guideline 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.
The guideline emphasizes 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 on how to do so.
In 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 rules that all clinical research professionals must follow.
I designed this course for any clinical research professional seeking to learn how to better design quality in their clinical studies and anticipate problems that may occur.
Together, I will walk you through the QbD concepts based on my experience, 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 and ICH GCP E6
Learn how to identify Critical to Quality factors
Identify and understand the ICH E8 requirements for optimal design and conduct clinical studies
Understand and learn 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 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
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.
Welcome to this ICH E8(R1) course to design quality into your Clinical Studies !
The ICH E8 (R1) is the umbrella guideline of the ICH family and works hand-in-hand with the ICH E6 Good Clinical Practice (R3) guideline.
This guideline 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.
The guideline emphasizes 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 on how to do so.
In 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 rules that all clinical research professionals must follow.
I designed this course for any clinical research professional seeking to learn how to better design quality in their clinical studies and anticipate problems that may occur.
Together, I will walk you through the QbD concepts based on my experience, 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 and ICH GCP E6
Learn how to identify Critical to Quality factors
Identify and understand the ICH E8 requirements for optimal design and conduct clinical studies
Understand and learn 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 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
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.
User Reviews
Rating
Dr. Vincent Baeyens
Instructor's Courses
Udemy
View courses Udemy- language english
- Training sessions 27
- duration 2:31:00
- Release Date 2023/06/11
