e-Learning: Global Stability - Stability testing for chemical and biological products in the ICH region and beyond

- Basics and regulatory requirements - Factors influencing stability - Stability testing requirements - Bracketing and matrixing - Storage conditions - Shelf life/re-test and extrapolation - Dossier structure - Impact of changes on stability - Global stability program - Challenges for biological productsGlobal Stability: This e-Learning provides a comprehensive introduction to global stability testing for pharmaceutical products (chemical and biological products). Including an update on revision of the guideline ICH Q1.LernzieleThis e-Learning (newly created in Q1-2026) provides a comprehensive introduction to global stability testing for pharmaceutical products.It includes an update on the revision of the ICH Q1 guideline and what it means for your day-to-day work.- Across 10 self-paced modules combining video, audio, and (interactive) text elements, you will explore the regulatory landscape, key stability concepts, and the requirements that apply throughout a products entire lifecycle.- By completing this course, you will gain a solid understanding of how stability studies are designed, conducted, and evaluated to ensure that medicines remain safe and effective for patients worldwide.ZielgruppenThis e-Learning is designed for professionals working in pharmaceutical development, regulatory affairs, quality assurance, or CMC management who are involved in or responsible for stability-related activities.- It is equally valuable for anyone seeking a structured and up-to-date overview of global stability requirements.