Welcome to another episode of Queens of Quality. In this episode, we explore the key concepts of ICH (International Council on Harmonization), with a focus on the recent revisions to ICH E6R3 and ICH E8R1. These revisions bring significant changes to the pharmaceutical industry's regulatory landscape, emphasizing the importance of quality by design in clinical trials.
Tune in!
During this episode, you will learn about;
0:00:49 - ICH Introduction
0:02:13 - The Significance of ICH E6 and E8
0:04:41 - The Global Impact of ICH
0:08:02 - The Evolution of Technology
0:11:30 - Quality by Design
0:18:51 - Operational Feasibility
0:21:16 - Complementary Guidance
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