Course Code: REGA 5023
Academic Year: 2024-2025
This course examines the post-marketing requirements of licensed healthcare products. Students learn and apply the regulatory aspects of pharmacovigilance systems, including receipt and processing of case reports, literature reviews, post-marketing surveillance systems, signal detection, and safety reporting. Concepts such as safety information resulting in labeling changes and the principles of risk management systems, complaint handling, audits and inspections are also discussed and applied.