A Journey through the Pharmaceutical Regulation and Quality Design

from Queens of Quality Podcast · host Michelleanne Bradley, Jennifer DiMarco

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 Introduction0:02:13 - The Significance of ICH E6 and E80:04:41 - The Global Impact of ICH 0:08:02 - The Evolution of Technology0:11:30 - Quality by Design 0:18:51 - Operational Feasibility0:21:16 - Complementary Guidance Love the show? Subscribe, Rate, Review, Like, and Share!Let’s Connect!Connect with Queens of Quality;Website: https://metisconsultingservices.com/LinkedIn: https://www.linkedin.com/company/metis-consulting-services/Email: [email protected]

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This episode is 23 minutes long.

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This episode was published on October 24, 2023.

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