General Considerations ICH E8 (R1) for Clinical Studies
Complete Training Integrated into ICH GCP E6(R3) to Proactively Design Quality into Clinical Trials and Drug Development
3.70 (5 reviews)
11
students
2.5 hours
content
Oct 2024
last update
$13.99
regular price
What you will 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
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4808620
udemy ID
31/07/2022
course created date
26/05/2023
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