MiliWalsh
11-15-2007, 01:44 AM
The medical program of most American universities is a 40-unit degree curriculum that takes 21 to 24 months to complete. One of the required courses is an introduction to the pharmaceutical, biotechnology, and medical device industries, which provides an overview of the R&D process for each of these sectors. The program also requires students to take courses on food and drug law, good manufacturing practices, and investigational and marketing applications. Once students have completed the requisite coursework, they are required to complete a thesis or project report.
The elective courses in the curriculum are designed to expose students to further details about the impact of on the R&D effort. These electives include courses on medical device regulations, clinical trials, quality control, validation, and post-approval activities. In addition, three business courses on organizational behavior, operations management, and communication strategies are included in the curriculum to highlight the importance of working and communicating effectively in a team-based atmosphere.
For individuals interested in expanding their knowledge of regulatory affairs, but unable to commit the time and resources necessary to pursue a master's degree, most business universities also offer a certificate in regulatory affairs. Various organizations offer courses from the regulatory affairs program through the San Diego State University College of Extended Studies, and individuals can enroll in these individual courses to expand their expertise in regulatory affairs and gain university credit as well.
The elective courses in the curriculum are designed to expose students to further details about the impact of on the R&D effort. These electives include courses on medical device regulations, clinical trials, quality control, validation, and post-approval activities. In addition, three business courses on organizational behavior, operations management, and communication strategies are included in the curriculum to highlight the importance of working and communicating effectively in a team-based atmosphere.
For individuals interested in expanding their knowledge of regulatory affairs, but unable to commit the time and resources necessary to pursue a master's degree, most business universities also offer a certificate in regulatory affairs. Various organizations offer courses from the regulatory affairs program through the San Diego State University College of Extended Studies, and individuals can enroll in these individual courses to expand their expertise in regulatory affairs and gain university credit as well.