ALS 432: Writing an Orphan Drug Application
Course Number: ALS 432
Course Name: Writing an Orphan Drug Application
No. Units: 1.5
Faculty/Instructor(s): Ian Phillips
400-level Technical/Business Designations: Technical
Clinical and Regulatory Affairs: Elective
This course will equip students with an understanding on how to write an orphan drug designation application.
The students will learn about the Orphan Drug Act 1983 and the problems of developing therapies for rare diseases. The class will be sub divided into teams of 4-5 students. The teams will work on developing a professional, high standard, application. All participants will meet together with Dr Phillips for Q&A once a week. There will be regular meetings between each team and Dr Phillips to discuss progress.
The final product of the course is a complete application in a folder following all the FDA requirements. Companies / sponsors will be contacted by the teams to discuss their interest in sponsoring the proposal for submission to the FDA .