Drug Development in Industry and Regulatory Applications (PHR 781M)

This course reviews the industrial pharmaceutical product development process and FDA regulations currently applied in the USA for bringing an FDA-regulated medicine from research and development (R&D) to approval & market. The course will provide an overview of pharmaceutical product development steps and critical regulatory requirements through the development pathway, introduce essential regulatory documents, and summarize the critical information to interpret regulatory concepts. Students will be involved in projects, presentations, case studies, and discussions to help understand important development and regulatory elements and concepts.