RGA 6980 — Capstone: Practical Applications in Global Regulatory Affairs
3 semester hoursGraduateLecture
Offers practice utilizing practical and application-oriented exercises and discussions designed to translate global regulatory requirements for pharmaceutical, biologic, and medical device product commercialization into submission-ready documents and broadly applicable regulatory science solutions. Topics covered include creating submission-quality documents based on relevant statutes, regulations, and guidelines; completing medical device and biopharmaceutical product development Good Laboratory Practice documentation; conducting product testing; performing inspections; and effective utilization of GxP requirements. Summarizes the curricular content of the MS Regulatory Affairs program. Coursework consists of group and individual projects and research applicable to regulatory and industry information, as well as activities designed to aid in comprehending global regulatory issues.