Advanced Regulatory Affairs

Catalog description

In this advanced pharmacy practice experience (APPE) course (e.g., Advanced Regulatory Affairs rotation), students will deepen their understanding of pertinent US and Canadian regulations and law governing drug development. Additionally, students will be expected to apply what they learned in the perquisite course to support various regulatory projects and relevant regulatory strategies. This course includes a review and discussion of previous internal Regulatory Strategies and Health Authority meetings to further build competence in Regulatory strategy. Additionally, instruction will be given in the other dimensions of Regulatory Affairs including Regulatory Intelligence and Regulatory Chemistry Manufacturing and Controls. Lastly, students will receive instruction in how they can continue to deepen their understanding of regulatory affairs outside of the APPE rotation. Overall, the course is designed to provide the student knowledge, skill and regulatory experience needed to operate and perform on a regulatory affairs team within a pharmaceutical company.