General Considerations Ich E8(R1) For Clinical Studies

A Complete Guidance on the Principles and Best Practices for implementing Quality by Design (QbD) 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

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

Requirements

This course is dedicated to intermediate as wells as to more advanced professionals willing to learn how to design quality into their clinical studies

Prior working experience or knowledge in clinical research is recommended to attend this course

Description

Welcome to this course on General Considerations ICH E8(R1) for Clinical Studies !ICH E8(R1) is the umbrella guideline of the ICH family and works hand-in-hand with the ICH E6(R3) Good Clinical Practice. 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 ResearchUnderstand the link between ICH E8 and ICH-GCP E6Learn how to identify Critical to Quality factorsIdentify and understand the ICH E8 requirements for optimal design and conduct clinical studiesUnderstand and learn how to apply the process to implement good design quality into clinical studiesLearn how to utilize good study design practice to optimize drug development planningUnderstand the key elements of the study protocol that may be used to optimize the design of a studyLearn from the experience in real case studies where QbD was implemented Vs not implementedThis course is dedicated to intermediate as wells as to more advanced professionals willing to learn how to design quality into their clinical studies. In order be able to apply the concepts, prior working experience or knowledge in clinical research is recommended to attend this course.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

Overview

Section 1: Introduction

Lecture 1 Welcome and Objectives of the Course

Lecture 2 Purpose of ICH E8

Lecture 3 Link between ICH E8 and ICH GCP E6

Section 2: General Principles of Clinical Research

Lecture 4 Protection of Clinical Study Participants

Lecture 5 Scientific Approach in Clinical Study

Lecture 6 Patient Input into Drug Development

Section 3: Process to Design Quality into Clinical Studies

Lecture 7 Strategy for implementing Quality by Design into Clinical Studies

Lecture 8 Definition of Critical to Quality Factors

Lecture 9 Approach to Identifying Critical to Quality Factors

Section 4: Quality by Design Principles in Drug Development Planning

Lecture 10 General Principles of Drug Development Planning

Lecture 11 Quality of Investigational Medicinal Product

Lecture 12 Scope and Timing of Non-clinical Studies with respect to Clinical Studies

Lecture 13 Optimizing Clinical Development Planning

Lecture 14 Additional Development

Lecture 15 Conclusions and Ways to Move Forward

Section 5: Quality by Design Elements to Design Effectively Clinical Studies

Lecture 16 Background and Rationale

Lecture 17 Definition of Study Population

Lecture 18 Treatment Description

Lecture 19 Choice of Control Group

Lecture 20 Response Variables

Lecture 21 Methods to Reduce Bias

Lecture 22 Statistical Analysis

Lecture 23 Study Data

Section 6: Quality by Design Approaches during Study Conduct, Safety Monitoring & Reporting

Lecture 24 Study Conduct

Lecture 25 Safety Monitoring during Study Conduct

Lecture 26 Study Reporting

Section 7: Quality by Design in Practice: Do's and Don'ts

Lecture 27 Case Studies and Assignment

Section 8: Conclusion and Final Quiz

Lecture 28 Conclusion

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.