Global stability: From regulatory framework to practical application - Including practical examples, case studies, a workshop and valuable tips & tric

- Regulatory landscape and testing requirements - Bracketing & matrixing, storage conditions and shelf-life - Dossier structure and post-approval changes - Challenges for biological products - Global stability program - Case studies and a workshop includedNavigate global stability requirements with confidence - from ICH, FDA and EMA frameworks to real-world application. In this interactive half-day seminar, you work through practical case studies, hands-on workshops and peer exchange to tackle the most common stability challenges head-on. LernzieleThe half-day course gives a comprehensive and practical understanding of global stability requirements for NCEs (New Chemical Entities) and NBEs (New Biological Entities) - from regulatory frameworks (including an update on the revision of the ICH Q1 guideline) to real-world application.- Through case studies, examples and hands-on modules, you will deepen your knowledge, sharpen your decision-making skills and learn how to tackle the most common stability challenges with confidence.You will leave with concrete tools and strategies that you can apply directly in your daily work.ZielgruppenThis seminar is designed for professionals in the pharmaceutical and biotech industry working in stability testing, regulatory affairs, quality assurance or product development, at any level of experience.