Pharmaceuticals: Canadian Regulations
The Canadian regulatory landscape is subject to many of the same types of pressures and trends as other jurisdictions and is continuously evolving. Both regulators and industry must adapt to new technologies, address consumers’ desire for greater involvement and transparency in healthcare decisions, accommodate the interest in harmonization and electronic requirements and respond to an increasing scrutiny of safety.
This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada. You will learn about the Canadian regulatory framework and applicable legislation for prescription drugs, nonprescription drugs and natural health products. Topics covered include the organization of Health Canada, Good Manufacturing Practices (GMPs), submissions, patent listing, labeling, advertising and promotion and postapproval changes.
At a Glance
- Target Audience: This program is designed for regulatory professionals and others in related departments interested in understanding the basics of the regulation of pharmaceuticals (prescription and nonprescription), radiopharmaceutical, natural health products and biologic products in Canada.
- Learning Level: Basic
- Total Length of Course: 6 Hours
- RAC Points: 6
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:
- Identify applicable legislation and recognize how it fits within the Canadian framework
- Classify drugs and understand factors impacting change of classification
- Understand Health Canada’s organization and agency interactions
- Recognize types of preapproval submissions
- Comprehend timing requirements, eligibility criteria and methods of application of intellectual property protection
- Categorize postapproval changes and submissions
- Identify various types of postapproval activities
- Apply knowledge in the development of a regulatory strategy plan for different product types
Lesson Titles
- Lesson 1: Canadian Legislative Framework
- Lesson 2: New Drugs
- Lesson 3: Old Drugs
- Lesson 4: Clinical Trials and Special Access Programme
- Lesson 5: Nonprescription Drugs/OTC Drugs
- Lesson 6: Good Manufacturing Practice (GMP)
- Lesson 7: Drug Labeling, Advertising and Promotion
- Lesson 8: Postmarketing Activities
This course is also included in:
