The regulation of healthcare products is dynamic and challenging, and the demand for qualified professionals is rising at an exceedingly swift pace. Whether you are a student considering pursuing a regulatory career, an individual transitioning into regulatory from a related career or someone already working in the field who wants to expand their skills, this is the course for you!
Introduction to Regulatory Affairs and the Healthcare Product Lifecycle will introduce you to 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 major agencies in the US, European Union (EU), Canada, Japan and Australia, as well as typical tasks and roles regulatory professionals may assume within a company. This course will give you a strong sense of what a regulatory career encompasses, and if you are already working in or transitioning to the profession, it will quickly bring you up to speed on critical topics.
Learning Objectives
Upon completion of this course, participants should be able to:
- Define and give examples of healthcare product types
- Describe the stages of the healthcare product lifecycle
- List common responsibilities of regulatory professionals
- Identify regulatory agencies in major regulatory systems
- Discuss the harmonization bodies for major healthcare product types
Target Audience
This course would benefit anyone preparing to enter the regulatory profession, individuals who are transitioning from a related-field or who want to expand their skills in project management and who are considering or working in the following settings:
- Healthcare product companies
- Government regulatory agencies
- Consulting or law firms
- Academic research centers