Management of Global Regulatory Submission

Course Code: REGA 5031

Academic Year: 2019-2020

This course builds on the regulatory framework and foundation covered in REGA 5020 to provide students with the practical experience in preparing regulatory submissions to Health Canada for various types of health products. Students will gain knowledge of project management processes and their application to regulatory submissions. Submissions for natural health products, a Drug Identification Number, biologics, veterinary drugs and other smaller miscellaneous filling will be discussed. This course will equip students with skills necessary for global regulatory submissions, such as identifying the required type of submission (i.e. clinical trials or launching of a new drug) as well as planning and preparing such submissions for review by respective regulatory agencies. Case studies will be used to provide a practical experience in understanding and applying international regulations and legislations, including US and EU. Additionally, students will become skillful at utilizing software commonly applied in the regulatory affairs field. Overall, the course focuses on the processes and regulations associated with the area of global regulatory affairs. Students will become familiar with the legislative framework and regulations that guide the selection and designation of medical products globally.