LAW 785S Legal Regulation of Pharmaceutical and Medical Device Research and Development 3.0 Credits
This course explores the regulatory entities and schemes governing the research and development, management, financing, and reporting requirements of clinical trials in the pharmaceutical and life sciences sectors. Topics include the role of the Institutional Review Board, compliance with Good Clinical Practice standards, informed consent, pharmacovigilance and the protection of human research subjects, payments and financial transparency, conflicts of interest, ethical considerations in designing and executing clinical trials, and reporting requirements.
College/Department: Thomas R. Kline School of Law Repeat Status: Not repeatable for credit
In order to graduate, all students must pass three writing-intensive courses after their freshman year. Two writing-intensive courses must be in a student's major. The third can be in any discipline. Students are advised to take one writing-intensive class each year, beginning with the sophomore year, and to avoid “clustering” these courses near the end of their matriculation. Transfer students need to meet with an academic advisor to review the number of writing-intensive courses required to graduate.
For additional information, and an up-to-date list of the writing-intensive courses being offered, students should check the Drexel University Writing Center page