Management of Global Regulatory Submission

Course Code: REGA 5031

Academic Year: 2020-2021

This course builds on the regulatory framework and foundation, providing students with practical experience in preparing regulatory submissions for various types of health products. Students gain knowledge of project management processes and their application to regulatory submissions. This course equips students with skills necessary for global regulatory submissions, from selection of submission type to planning, and preparing such submissions for review by respective regulatory agencies. Students become familiar with the legislative framework and regulations that guide the selection and designation of medical products globally. Case studies are used to provide practical experience in applying international regulations and legislations, including EU and US. Students are also introduced to software commonly used in the regulatory affairs field.