Regulatory Intelligence and Policy

Catalog description

In this advanced pharmacy practice experience (APPE) elective course students will deepen their understanding of pertinent regulations and law governing drug development. Additionally, students will be expected to apply what they learned in the perquisite course to support various regulatory research projects and identify relevant regulatory intelligence information. This course will also afford exposure and interaction with Regulatory Affairs colleagues in Intelligence & Policy, Strategy, Advertising and Promotion, Operations, Labelling, and Chemistry, Manufacturing & Controls (CMC). Additionally, students may have the opportunity to contribute to Regulatory Intelligence & Policy activities beyond support for Regulatory Affairs including Quality Assurance, Supply Chain, Manufacturing, Pharmacovigilance, Research, Clinical Development and/or Medical Affairs. Lastly, students will receive instruction in how they can continue to deepen their understanding of regulatory affairs and source regulatory intelligence information 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.