Regulatory Affairs Certificate
AAPS’ Regulatory Affairs program provides students with the skills, techniques and knowledge needed for a career in regulatory affairs. Regulatory affairs is an increasingly important profession in the pharmaceutical industry, necessary for controlling the safety and efficacy of medicinal products, pharmaceuticals, medical devices and food supplements.
Students will gain working knowledge of a wide range of standards and regulations, including good manufacturing practices, good laboratory practices, post approval activities, regulatory compliance, the Canadian Food and Drugs Act as well as Global Regulatory Strategies.
Introduction to Regulatory Affairs: Quickly develop your understanding of Pharmaceutical Regulatory Affairs with this concise course format where you’ll learn all about the rules and regulations that affect pharmaceutical, biological, natural health products and medical devices. This course also covers international food and drug laws, regulations and guidelines.
Regulatory Submissions: Gain hands-on experience with various types of regulatory submissions. You’ll learn about the completion and application of regulatory submissions such as CTA, NDS/A, ANDS/A, and CTD, and gain understanding of the regulatory review process, and successful submission strategies.
Chemistry, Manufacturing and Control: Learn to develop a cost effective, risk managed CMC regulatory compliance strategy to move products into commercialization and maintain CMC regulatory compliance after products receive market approval.
Regulatory Affairs Generic Drugs: Learn all about the background, product development process, and regulatory requirements of genetic drugs.
Post Approval Activities and Compliance: This course will help students understand the various regulatory activities that take place post-approval by analyzing examples from the current regulatory industry. This course also illustrates effective filing of notification techniques, and discusses common issues that arise for pharmaceutical firms.
Regulatory Affairs for Natural Health Products: Gain an in-depth understanding of the Canadian, US, and EU regulatory and compliance requirements for Natural Health Products.
Regulatory Affairs for Biologics/Biotechnological Products: Biologics and Biotechnology products have different regulatory requirements for their approval from regulatory agencies. Learn the details of biological drug product development and the requirements for successful submissions.
Medical Devices: This course helps students define medical devices, explains existing regulations regarding device approval, and outlines clinical research and involving medical devices.
Global Regulatory Strategies: This course provides students with a clear understanding of the Canadian, US, and European regulatory requirements for bringing a drug product to market, and also focuses on major strategic issues facing drug submissions.
Labelling and Product Summaries: This course is focused on labelling and product summaries requirements, covering topics such as Product Monograph, Package Insert, Summary of Product Characteristics, and more.
Introduction to Clinical Research and Drug Safety: Learn about the clinical research, clinical safety and pharmacovigilance functions in the drug development process from both Canadian and international perspectives.
Food Act and Regulations: Gain fundamental knowledge of regulations outlined in the Food and Drug Regulations guidelines, and learn how this knowledge can be applied to help food processors of all sizes develop new products, manufacture existing products, and distribute safe food products.