With financial support from the BC Ministry of Advanced Education and Skills Training, the UBC Academy of Translational Medicine (ATM) has partnered with UBC Extended Learning to offer the UBC Micro-certificate in Regulatory Affairs for the Life Sciences. This program consists of two five-week part-time courses, which will run back-to-back September to November 2022, that can be taken separately or stacked into a UBC Micro-certificate.
British Columbia has the fastest growing life sciences sector in Canada, and regulatory expertise is vital to the continued growth of the sector. This new micro-certificate is tailored to the unique bio-innovation landscape of BC and will equip learners with highly sought-after skills critical for the life sciences, biotechnology, biomanufacturing, medical device and pharmaceutical industries.
The first course, Introduction to Regulatory Affairs, provides an overview of the Canadian and global regulatory affairs landscape and its major stakeholders, and covers basic tools for evaluation safety and efficacy, regulatory requirements for clinical trials, and regulatory process pathways for medical devices. The second course, Regulatory Sciences and Health Economics, explores the emerging discipline of regulatory science, including real-word evidence, adaptive clinical trial design, patent law, health economics, post-market surveillance and regulatory reform. The two courses are five weeks each, with an average weekly commitment of 5−7 hours.
This online program combines self-paced independent study, weekly facilitated online sessions, and on-campus workshops that includes real-world UBC case studies. A remote virtual option is available for the workshops.
Spaces are limited, and are first-come, first-served. A limited number of financial subsidies are available to UBC Faculty of Medicine students, trainees and faculty members, as well as under-served learners.
Read more about the course on the ATM website