WS07.2 – Navigating the Complexities of Packaging and Labeling for Investigator-Sponsored Trials (ISTs) (I)

This intermediate level workshop explores the unique complexities and common pitfalls in managing packaging and labeling for ISTs, including navigating country-specific regulations, GMP compliance, and timelines when sponsors are academic institutions or individual investigators. Participants will leave with practical tools, risk mitigation strategies, and collaboration models to better support ISTs without compromising quality or regulatory integrity.