Recent developments in nitrosamine risk assessment, testing, and mitigation for medicinal products will be reviewed from both regulatory and technical perspectives. The session will include two presentations from experts in the industry and regulatory agencies followed by Q&A.
Learning Objectives:
Upon completion, participant will be able to be aware of the challenges posed by Nitrosamines in pharmaceuticals globally.
Upon completion, participant will be able to learn conducting a comprehensive risk assessment and mitigation strategy for standard nitrosamines and New Drug Substance Related Impurities (NDSRIs) for product lifecycle
Upon completion, participant will be able to get a comprehensive grasp of expectations, complexities, and diversities on nitrosamines control strategy by global health authorities
