The regulation of healthcare products is dynamic and challenging, and the demand for qualified professionals is rising at an exceedingly swift pace. Over the years, regulations have evolved on conducting testing and clinical trials, documentation, manufacturing processes, labeling and advertising, and other facets of developing a product, including market launch and distribution.
This course will present essential areas of regulatory knowledge across a broad range of healthcare products, including medical devices, pharmaceuticals, biologics and combination products. You will also learn about key regulatory systems and mechanisms and major agencies in the United States (US), European Union (EU), Canada, Japan and Australia.
Learning Objectives
Upon completion of this course, participants should be able to:
- Define and give examples of healthcare product types
- Identify regulatory agencies in major regulatory systems
- Discuss the harmonization bodies for major healthcare product types
- Identify regulatory agencies in major regulatory systems
- Describe regulatory processes and mechanisms for each system
Target Audience
This course is intended for professionals new to the regulatory profession or transitioning from a related field, including those employed with healthcare product companies, government regulatory agencies, consulting or law firms and academic research centers.