Tutor information
Lee Smith
Dr. Lee Smith’s experience spans biopharmaceutical CMC, process, analytical, formulation pre-clinical and clinical assay development as well as experience in product characterisation and regulatory submissions and interactions. He is regularly involved in applying QbD and advising on the use of DoE and data analysis for processes, formulation and assays, with a particular expertise in bioassays. This includes the development, optimisation and validation of both biopharmaceutical processes and methods.
Courses
An overview of pre-clinical testing and pathway from pre-clinical testing to field trials, discussions of vaccine immunogenicity, phases of vaccine testing from Phase I to IV, and the development and manufacturing of vaccines with our expert presenters.