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Fundamentals of Regulatory Affairs

This course provides a survey of all the activities undertaken to gain approval of a new drug or medical device in the US. 

Course Overview: 

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.

Who Should Attend: 

Those who are working in Pharmaceuticals and want to know more about Regulatory Affairs.

Prerequisites: 

Students are expected to have some knowledge of the Pharmaceutical industry and a Bachelor's Degree.

Course Outline: 
  •     Introduction to Regulatory Affairs
  •     FDA Communications and Meetings
  •     Pharmaceuticals
  •     Biologics
  •     Medical Devices
  •     Other Products - OTCs, dietary supplements, Cosmetics, vet products.
  •     Intellectual Property - Copyrights, Trademarks, Patents & Trade Secrets.
  •     Quality Assurance - GxPs
  •     Labeling
  •     Post Marketing Surveillance and Regulatory Intelligence

All offerings of this course: