Program Description
This program tackles the regulatory processes in USA and Europe, providing a detailed knowledge that enables students of understanding the history, requirements, and process required for registration of Drugs and Medical Devices in the concerned regulatory authorities. Introducing drug’s lifecycle starting from clinical studies and ending by a finished product that enters the market, as well as, going through the medical device’s processes and comparing the requirements between both authorities.
Program Objective
A 14-hour credit program that is designed to create Regulatory Affairs professionals who have the know-how of regulatory processes and are able of dealing with the regulatory authorities in USA and Europe (USFDA and EMA respectively). To enrich the program and make it a unique experience for students, the curriculum includes a variety of learning methods such as critical thinking which helps in demonstrating the actual case for students.