COURSE Code: REGA 506
4 Credits
Course Description
In this course, students will gain knowledge in submission processes, guidelines and requirements. In addition, students will build skills in the researching and writing of various documents, dossiers and segments of those documents for federal, provincial and international medical device or biologic product approval. The course will be split in following modules: INDs, NDS/NDAs, CMC, DIN application and ANDS
