ALS 464: European Regulatory Affairs
Course Number: ALS 464
Course Name: European Regulatory Affairs
No. Units: 1.5
Faculty/Instructor(s): Susan Bain
This course will provide students with a broad background and understanding of the most current European Union regulatory requirements, strengthening their capacity to discuss, perform and address the regulatory requirements effecting licensure of products from the pharmaceutical and medical device industries. Students will become familiar with the regulatory requirements, enforcement and challenges posed when manufacturing and licensing products in the European Union. Students will be able to analyze, plan and navigate in the dynamic European Regulatory community.
Prerequisite of ALS 362 or Permission of Instructor (PPM; PPC)