This is the second of two courses in the UBC Micro-certificate in Regulatory Affairs in the Life Sciences.
While regulatory affairs is concerned with the administrative and legal aspects of regulations, regulatory science focuses on the tools and approaches used to assess the safety, efficacy, value and performance of health products. Regulatory science provides the scientific underpinnings of regulations, and helps regulators understand and assess risk and risk-benefit trade-offs.
Developed by the UBC Faculty of Medicine, and the UBC Academy of Translational Medicine’s Regulatory Advisory Council, this five-week course explores this emerging discipline, as well as patent regulations, post-market surveillance and regulatory reforms.
By the end of this course, you’ll be able to:
- describe patent law and regulations and their impact on healthcare
- outline post-market regulatory surveillance requirements, including understanding regulatory determinations of what constitutes “substantial evidence”
- explain trends in clinical studies, including the use of basket trials and adaptive clinical trial design
- describe the elements of real-world evidence generation, pharmacoeconomics and health economic evaluation
- understand socio-economic considerations, including methods for eliciting patients and risk-benefit trade-offs.
