British Columbia is home to the fastest growing life sciences sector in Canada. Challenging the growth of this sector, however, is the lack of skilled labour with regulatory and translational medicine expertise. Training in regulatory affairs and regulatory science is critically important to the future of the life sciences and research sectors in BC and Canada.
The UBC Micro-certificate in Regulatory Affairs in the Life Sciences is a part-time program delivered and developed by the UBC Academy of Translational Medicine (ATM) and the UBC Faculty of Medicine in consultation with world leaders in regulatory affairs. It offers a well-rounded, foundational understanding of Canadian and global regulatory systems, processes and stakeholders.
Consider tasks that make up regulatory affairs and translational medicine, including risk-benefit analyses, preclinical and clinical requirements, evidence generation and regulatory strategy development. Gain essential knowledge of clinical trials, medical device regulations, patent regulation, post-market surveillance, master protocol and adaptive clinical trial design. Explore the emerging discipline of regulatory science and its intersection with real-world evidence, patient engagement and health economics.
- Format: Blended, with bi-weekly live online sessions facilitated by your instructor, and an on-campus workshop for each course (a virtual option using Zoom is available so you can complete the program entirely online)
- Duration: Two courses of ten weeks each, a total of 50–70 hours of course work
- Cost: $1,250 per course (Canadians and permanent residents); $2,500 per course (international students)
- Next intake: September 11, 2023
Open all | Close all
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 the two courses, you’ll be able to:
- identify the key stakeholders and agencies involved in Canadian and global regulatory systems
- understand the basic tools for evaluating the safety and efficacy of drugs and health products
- identify the stages of a clinical trial and identify associated regulatory requirements
- describe the process pathway 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, pharmacoeconomics, and health economic evaluation
- understand socio-economic considerations, including methods for eliciting patients and risk-benefit trade-offs.
Who is This Program For?
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.
This part-time blended program is instructor-supported, and combines bi-weekly modules facilitated and pre-recorded online sessions, self-paced independent study, and two in-person workshops. A virtual option using Zoom is available for the workshops so you can complete the program entirely online. See course descriptions for days and times of the live online sessions and workshops.
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.
Outside of class time, you can access online materials at your own pace. Each module, review readings, case studies, videos and podcasts. Contribute to an online discussion forum where you can apply your learning.
One business day before the course start date, we’ll email you step-by-step instructions for accessing your course.
Expect to spend 5-7 hours in each two-week interval completing all learning activities, including the option of attending periodic live online sessions and attending the in-person workshop.
To take this program, you’ll 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.
The program consists of two courses of ten weeks each. Combined, the courses take 50–70 hours to complete. Take courses individually, or in sequence. However, to gain the most value from the program and earn your micro-certificate, we recommend taking both courses as they complement one another.
Introduction to Regulatory Affairs provides an overview of the Canadian and global regulatory affairs landscape and its major stakeholders, and covers basic tools for evaluating safety and efficacy, regulatory requirements for clinical trials, and regulatory process pathway for medical devices.
Regulatory Science and Health Economics explores the emerging discipline of regulatory science, including real-world evidence, adaptive clinical trial design, patent law, post-market surveillance, health economics evaluation, patient preferences for risk-benefit trade-offs, and evidence needed for reimbursement.
In the fifth module of each course, in place of the online class you attend an in-person workshop in Vancouver. See course description for details.
How am I Assessed?
You’re assessed on your proficiency in core competencies you demonstrate in assignments and weekly reflections on course contents, as well as your participation in live 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 specific and actionable feedback.
This course is pass/fail. You must achieve an overall grade of 70% or greater to pass and earn a micro-certificate.
Our lead program developer and instructor is Dr. Dean Regier, Associate Professor, School of Population and Public Health and Senior Scientist, BC Cancer Research Institute. Read Dr. Regier’s bio.
Guests vary by session, and include regulatory experts, faculty, instructors and industry professionals, who present and share their expertise with students:
- Dr. Nicole Taylor Smith, Vice President, Global Regulatory Policy at Medtronic
- Isabelle Gerges, Senior Director, Quality and Regulatory Affairs at Medtronic
- Nancy Shadeed, former Manager of International Programs, Health Canada
- Dr. Tania Bubela, Professor and Dean, Faculty of Health Sciences, Simon Fraser University
- Dr. Samantha Pollard, Senior Methodologist, BC Cancer Research Institute
- Deirdre Weymann, Senior Health Economist, BC Cancer Research Institute
- Melanie McPhail, Research Associate, Simon Fraser University
- Jean Smart, Regulatory Affairs and Quality Officer (Clinical Trials BC) and Privacy Officer, Michael Smith Health Research BC, Principal of SQAS
- Fenton Fong, Managing Director, xCellerate Technology Consulting
|Course||Course Fee – Canadians and Permanent Residents||Course Fee – International Students|
|Introduction to Regulatory Affairs||$1,250||$2,500|
|Regulatory Science and Health Economics||$1,250||$2,500|
Course fees are in Canadian dollars and subject to change. Fees may be paid by Visa®, Mastercard®, cash, money order or certified cheque.
Please see Refunds, Cancellations and Transfers for details on our policies.