This is one of two courses in the UBC Micro-certificate in Regulatory Affairs in the Life Sciences.
As a 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 help 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 five-module course offers an introductory overview of Canadian and global regulatory affairs.
By the end of this course, you’ll be able to:
- Understand the context for health product regulations, describe the Canadian, US and European authorities and their processes, and identify the key requirements for regulatory submissions and post-approval obligations.
- 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 requirements for good manufacturing practices across the product life cycle, active pharmaceutical ingredients (small molecules, biologics and ATMPs), drug products (dosage forms, sterile processing, lipid nanoparticles).
- Describe the classification, licensing requirements, and license application pathways for medical devices.
Course outline
Module 1: Introduction to Regulatory Affairs - Overview
Learn about the origins of regulations, the drug development continuum, the Canadian, US and European authorities that regulate healthcare products, and get an overview of regulatory submission and post-approval requirements.
Module 2: Clinical Trial Regulations
Understand the key concepts in clinical trial regulations, including the regulatory processes relevant to the management and operations of clinical trials. Review important international harmonized guidance and the principles of Good Clinical Practice.
Module 3: Nonclinical Studies
Review the nonclinical study package needed to support human clinical trials. Specifically, the elements of the Investigator’s Brochure: pharmacology, pharmacokinetics, toxicology and metabolism.
Module 4: Chemistry and Manufacturing
Review the elements of good manufacturing practices (GMP), and understand the requirements for active pharmaceutical ingredients, drug products, formulation, sterilization, and finishing. We will also review process development and validation as part of the product life cycle.
Module 5: Medical Device Regulations
This module provides an overview of regulatory principles and concepts for medical devices. Module 5 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 assignments and weekly reflections on course content, as well as your participation in bi-weekly 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 module and provide a short response to another peer’s reflection. Reflections and peer reviews are graded out of six marks in total and contribute to the final grade. A virtual question and answer (Q&A) session with the module instructors will be held bi-weekly for each of Modules 1-4. Students are expected to submit questions for at least 2 of the 4 Q&A sessions. After 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 case study assignment to demonstrate how you would apply your regulatory skills. After the workshop, a second assignment with a mixture of multiple choice and short answer questions will test your understanding of the final two modules of the course. Your work is marked on a matrix using a scoring guide, and your instructor provides you with specific and actionable feedback.
Learner evaluation
Class reflections and student participation: 30% Assignment 1: 30% Workshop Project: 20% Assignment 2: 20% The course is pass/fail. You must achieve an overall grade of 70% or greater to pass. Both courses within the Regulatory Affairs in the Life Sciences Program — Introduction to Regulatory Affairs and Regulatory Science and Health Economics — must be taken and passed to earn a micro-certificate.
Expected effort
Expect to spend five to seven 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. Please see Available sessions below for current offering dates and in-house workshop date and time. Students can check the course schedule in canvas to learn of any changes to the day and time of the live online sessions and in-person workshop. 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.
