Stability & Shelf Life of Biologics (https://fleming.events/stability-shelf-life-of-biologics/)
Italy
Organization: Fleming Events
Event: https://fleming.events/stability-shelf-life-of-biologics/
The Stability & Shelf Life of Biologics Training Course 2026 is a premier professional development program designed for experts working in biologics, biopharmaceuticals, biotechnology, regulatory affairs, quality assurance, quality control, formulation development, and analytical sciences. Taking place on 27–28 October 2026 in Rome, Italy, and available through a live online stream, this intensive training provides a comprehensive understanding of stability testing, shelf-life assessment, and regulatory expectations for biologic products.
Participants will explore critical topics including ICH Q5C guidelines, accelerated stability studies, stress testing, biologics degradation, protein stability, monoclonal antibodies, biosimilars, analytical method validation, formulation strategies, excipient selection, packaging validation, transport and shipping impacts, cold chain management, and product lifecycle management. Through expert-led presentations, case studies, workshops, and interactive discussions, attendees will gain practical knowledge that can be directly applied to product development and regulatory submissions.
The course also covers European regulatory frameworks, stability protocol design, comparability studies, stability data analysis, and shelf-life justification for biologics throughout clinical development and commercialization. This training offers a valuable opportunity to network with industry professionals, regulatory experts, and decision-makers while gaining insights into the latest trends and best practices in biopharmaceutical quality and compliance.
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Karthik Naik