This is one of two courses in the UBC Micro-certificate in Regulatory Affairs in the Life Sciences.
As a hub and liaison between research, industry and government bodies, regulatory affairs play a key role in the pharmaceutical and medical device industries. Through every stage of the lifecycle, regulatory professionals are responsible for helping bring new products to market that are safe and effective – from research and development to testing, manufacturing, marketing, and ongoing quality assurance and compliance.
Developed by the UBC Faculty of Medicine, and the UBC Academy of Translational Medicine’s Regulatory Advisory Council, this ten-week course offers an introductory overview of the Canadian and global regulatory affairs landscape.
By understanding the central themes of Regulatory Affairs in the Life Sciences, by the end of this course, 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
- describe clinical trials and identify their associated regulatory requirements
- describe the process pathway for medical devices
Course outline
Module 1: Introduction to Regulatory Affairs
Learn about the agencies that regulate healthcare products, including Health Canada and the US Food and Drug Administration. Gain a bird’s-eye view of the regulatory process for marketing drug and health products.
Module 2: Health Products Evaluation: An Introduction
Clinical epidemiology and biostatistics study the effects of healthcare decisions. In this module, describe the basic statistical tools needed for evaluating the safety and efficacy of drug and health products.
Module 3: Clinical Trial Regulations: Overview and Processes
Understand the key concepts in clinical trial regulations, including the regulatory processes relevant to the management and operations of clinical trials.
Module 4: Biomanufacturing and Quality Control
Federal legislation, regulations and guidance documents set out the requirements for good manufacturing practices (GMP). Get an overview of licensing requirements, quality control systems and inspections, including issues unique to the biomanufacturing context.
Module 5: Key Concepts in Medical Device Regulations
This module introduces medical device products, and provides an overview of regulatory principles and concepts for medical devices. Week 10 includes a workshop in lieu of an online class on medical device regulation.
How am I assessed?
You’re assessed on your proficiency in core competencies you demonstrate in an assignment and weekly reflections on course content, as well as your participation in live online sessions, online discussion forums, and the workshop.
Students are expected to articulate three separate reflections in point-form on the core concepts learned during each weekly lecture. Reflections are graded out of six marks total, and contribute to the final grade.
During module 3, students will be given an assignment with a mixture of multiple choice and short answer questions to test their knowledge on the first three modules of the course.
The workshop features a final case study assignment 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.
Learner evaluation
Class reflections and student participation: 30%
Assignment: 30%
Workshop Project: 40%
The course is pass/fail. You must achieve an overall grade of 70% or greater to pass and earn a micro-certificate.
Expected effort
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 workshop.
Technology requirements
To take this course, 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.
Course format
This part-time blended program is instructor-supported and combines periodic bi-weekly facilitated live and pre-recorded online sessions, self-paced independent study, and an in-person workshop. A virtual option using Zoom is available for the workshop so you can complete the program entirely online. The live online sessions will also be recorded.
The days and times of the live online sessions are to be determined. In the fifth module of the course, you can attend an in-person workshop in Vancouver. The workshop takes place on Friday November 17, 1-4pm PT and Saturday November 18, 10am-1pm PT.
You can access online materials at your own pace. For each module, review readings, videos, and podcasts. Contribute to an online 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.