This is an updated Regulatory Affairs course intended for Alumni of the UBC Micro-certificate in Regulatory Affairs in the Life Sciences. It includes new instructors, new modules, and updates to previously presented material. It is intended for independent learning and there are no assessments.
As a liaison between research, industry and government bodies, regulatory affairs play a key role in the pharmaceutical and biologics 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 four-module refresher course offers an 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).
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.
Expected effort
Expect to spend three to five hours to complete each module.
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 virtual program is intended for self-paced independent study and can be complete entirely online. You can access online materials at your own pace. For each module, review videos, and additional reference material. Contribute to an online forum with other RALS alumni. Upon registration, we will email you step-by-step instructions for accessing your course.
Meet your instructors
- Maryann Rogers
- Karen Long
- Jean Smart
- Pat Tam
- John Harmer