Pharmaceutical Industry New Drug Development
This course is designed to provide the student with an in-depth understanding of the pharmaceutical research and development process and the role of Information Technology (IT) in this process, with the goal of helping the student to be an effective provider of information system development and operations in this arena. The various phases of the process will be described in detail, including key regulatory imperatives and the role of project management. The current contributions of IT to each phase will be reviewed; the global perspectives on international harmonization and worldwide submissions will be discussed; the economics of IT in drug R&D will be highlighted; illustrative case studies will be presented; and a view of the future of IT in R&D will be put forth. Topics include organizational models in R&D and IT, a comprehensive view of the main components of the R&D process, current contributions of IT to each of the main components of the R&D process, the global perspective, and the economics of IT in drug development.