Regulatory Affairs in the Life Sciences

The UBC Micro-certificate in Regulatory Affairs in the Life Sciences equips you with highly sought-after skills critical for the Canadian and international life sciences, biotechnology, biomanufacturing, medical device and pharmaceutical sectors.

By the end of this program, you’ll be able to:

• understand the context of health product regulations, and the regulatory submission and approval processes in Canada, the US and Europe
• understand the clinical trial phase of product development, with special emphasis on quality requirements, good clinical practice and ongoing compliance expectations
• identify requirements for nonclinical testing, including pharmacology, toxicology, pharmacokinetics, and metabolism to support clinical trial applications
• describe the elements of good manufacturing practice across the product life cycle, and the requirements for active pharmaceutical ingredients and drug products
• describe the classification, licensing requirements, and license application pathways for medical devices
• describe patent regulation and its impact on healthcare
• outline post-market regulatory surveillance requirements, including understanding regulatory decisions based on sufficient evidence
• explain emerging evidence trends, including the use of basket trials and adaptive clinical trial design
• describe the elements of real-world evidence generation, pharmaco-economics, and health economic evaluation
• understand socio-economic considerations, including methods for eliciting patients and risk-benefit trade-offs

This program is designed for professionals who work in health, life sciences and related sectors who want to:

• understand regulatory affairs and translational medicine
• build their knowledge of the regulation of drug and device development processes
• understand the emerging discipline of regulatory science and its intersection with real-world evidence, patient-oriented research and health economics

Students and faculty in the disciplines of life sciences, clinical health services and population health will benefit from understanding the regulatory and translational medicine landscape, and the frameworks used to approve and market drug and health products.

For Canadians and permanent residents each course costs $1,300 and the total cost of the program is $2,600. For international students, each course costs $2,600 and the total cost of the program is $5,200.

All fees are in Canadian dollars, subject to change and to GST (where applicable). For details on forms of payment accepted, please see How to pay.

Find more details on refunds, cancellations and transfers.

The program consists of two courses of five modules each. Combined, the courses take 50 to 70 hours to complete.

You can take the courses on their own, in any order. However, to gain the most value from the program, we recommend taking the courses in succession as they build upon one another. You must complete both courses to obtain your micro-certificate.

Required Courses

This part-time blended program is instructor-supported and combines bi-weekly real-time live sessions and pre-recorded online classes, independent study, and two in-person workshops. A virtual option using Zoom is available for the live sessions and workshops so you can complete the program entirely online.

In the fifth module of each course, you attend an in-person workshop in Vancouver instead of the online class. These workshops include real-world case study assignments based on regulatory developments out of UBC that offer you an opportunity to apply your knowledge and regulatory skills.

Both online live sessions and in-person workshops are recorded. We encourage attendance as learners will engage in mutual learning and knowledge exchange.

Outside of classes and workshops, you can access online materials on your own time. For each module, you can review readings, case studies, videos and podcasts, as well as contribute to an online discussion forum where you can apply your learning and connect with other students.

Expected effort

Expect to spend five to seven hours per week completing all learning activities, including attending bi-weekly real-time online sessions and attending the in-person workshop.

Technology requirements

To take this program, you need access to:

• an email account
• a computer, laptop or tablet
• the latest version of a web browser (or previous major version release)
• a reliable internet connection
• a video camera and microphone

Assessment

You are assessed on your proficiency in core competencies you demonstrate in assignments and weekly reflections on course contents, as well as your participation in real-time online sessions, online discussion forums, and the workshops. The workshops culminate in final case study assignments and are designed to demonstrate how you would apply your regulatory skills.

Your work is marked on a matrix using a scoring guide, and your instructor provides you with specific and actionable feedback.

Regulatory Affairs in the Life Sciences is pass/fail. You must achieve an overall grade of 70% or greater in both courses to earn a micro-certificate.

Our program instructors are experts with extensive industry experience along with renowned guest speakers specializing in the field. The lead program developer and instructor is Dr. Dean Regier.

Guest instructors

Guests vary by session, and include regulatory experts, faculty, instructors and industry professionals, who present and share their expertise with students:

• Dr. Dean Regier, Director, Academy of Translational Medicine, Associate Professor, UBC School of Population and Public Health, and Senior Scientist, BC Cancer Research Institute
• Karen Long, RAC (US, EU, Can, GS) Regulatory Affairs Lead, Academy of Translational Medicine
• Dr. Jean Smart, Regulatory Affairs and Quality Officer (Clinical Trials BC) and Privacy Officer, Michael Smith Health Research BC, Principal of SQAS
• Dr. Patrick Tam, Chief Development Officer, Mesentech and former director of development and preclinical pharmacology and toxicology at Aquinox, Forbes Medi-Tech and INEX Pharmaceuticals
• John Harmer, Aseptic processing consultant and former Vice President at Cytiva (formerly VanRx Pharmasystems)
• Dr. Hasnaa Fatehi, founder and CEO of QARALogic, founder and Executive Director of Western Medtech, Western Canada's network for Medical AI and Technology
• Deirdre Weymann, Staff Scientist, BC Cancer Research Institute
• Emanuel Krebs, Staff Scientist, BC Cancer Research Institute 
• Tania Bubela, Provost and Vice President, Academic and Deputy Vice Chancellor, Academic, Research and Extension, Aga Khan University, and Professor Emerita, Simon Fraser University Faculty of Health Sciences
• Melanie McPhail, JD, LLM, PhD Candidate, Peter A. Allard School of Law, University of British Columbia
• Jay Park, Assistant Professor, Department of Health Research Methods, Evidence and Impact, Faculty of Health Sciences, McMaster University and Scientific Lead, Core Clinical Sciences