Fundamentals of Regulatory Affairs
An overview of the laws, regulations, and regulatory agencies governing Pharmaceuticals, Devices, Biologics and Combination Products marketed in the US and in the world. The course also discusses the historical context in which the FDA evolved; its structure and its relationship with other US regulatory agencies. The course will provide an overview of market clearance pathways for drugs, biologics, medical devices and combination products so that the development and delivery of safe and effective healthcare products can be expedited. This course will emphasize teamwork, oral communication skills, and written communication skills.
- Introduction to Regulatory Affairs
- FDA Communications and Meetings
- Medical Devices
- Other Products - OTCs, dietary supplements, Cosmetics, vet products.
- Intellectual Property - Copyrights, Trademarks, Patents & Trade Secrets.
- Quality Assurance - GxPs
- Post Marketing Surveillance and Regulatory Intelligence
This class is also available through a continuing education option. Please see here to register.