Regulatory challenges

➡ Understand the landscape of emerging concerns regarding the presence of N-Nitrosamines (a class of organic compounds known for their potential carcinogenicity) in pharmaceutical products and the resulting investigations and recalls prompted by regulatory bodies.
➡ Explore how pharmaceutical developers are working to mitigate risk in current drug products and new APIs in development to assure they meet new, strict guidelines related to N-Nitrosamine presence or formation.
➡ Discover innovations in active material science that can be deployed in active packaging solutions to reduce or prevent nitrosamine formation and/or eliminate nitrosamines post-formation in the packaging headspace, minimizing the need for reformulation and reducing risk of recalls.