In this course, students will be introduced to basic concepts of toxicology and risk assessment and their applications to global regulations in the life sciences industry including food, pharmaceuticals and cosmetics. The course will cover safety tests and processes required for global life sciences product regulatory submissions and compliance verification in addition to required postlaunch safety surveillance. The course will be conducted online, following the format of the Professional Science Master’s Program.
By the end of this course, students will be able to:
• Describe basic concepts of toxicology (e.g. exposure assessment, dose/response analysis and extrapolation)
• Apply these concepts to global life sciences regulatory requirements
• Create global regulatory submission strategies for life sciences product categories
• Review and interpret results of safety studies to determine suitability for submissions
• Design safety surveillance processes for life sciences product categories
Technical Skills
Toxicology principles and test methods
Product safety surveillance
Human health risk assessment
Transferable Skills
Regulatory submissions
Safety study design
Product safety substantiation
Experiential Learning
Completing mock regulatory submission
Field trips to testing laboratories (in-person only)
Authoring safety substantiation file