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The Graduate Certificate has been developed with industry in mind, to supply reallife casestudies from authentic adventures, providing students with the most effective educational outcomes. Students will learn about the frame where regulatory affairs are ran through examination of their sources and current structure implemented by sponsor regulatory authorities. In addition, it examines the important integration of quality management fundamentals for effective implementation of regulatory affairs. Students will develop knowledge and skills from what's needed for regulatory supervision throughout the product placement, post-market vigilance and monitoring phases of the Product lifecycle. Students will develop strategies to balance business objectives and compliance with regulatory requirements throughout the analysis of dangers and unknowns with promotion strategies.
Tertiary qualifications or equivalent experience in the area of regulatory affairs.