Advanced Course CTD module 3 - Quality section 2026
This advanced course focuses on Module 3 (Quality) of the Common Technical Document (CTD) and provides a structured, in-depth overview of quality requirements for both drug substances and drug products.
Across two intensive days, participants will explore key topics such as analytical methods and validation, stability, impurities, pharmaceutical dosage forms, and the regulatory expectations underpinning quality documentation. The course also addresses variations to Module 3, combining regulatory insights with practical, case-based workshops.
Delivered by experts from regulatory authorities, academia, and industry, this course is designed for professionals seeking to strengthen their understanding of quality dossiers and to apply regulatory principles effectively in real-world scenarios.