PRACTICUM

The Biomedical Regulatory Affairs practicum provides a practical experience to ensure that students can shepherd new medical products (drug, device and biologic) through regulatory, clinical and quality assurance aspects. You will work on projects of your choice under the guidance of an adviser. You refine your work as you progress in the program and produce a final report. This is an independent study course, but you will be required to participate in group presentation sessions. These sessions provide an opportunity to share knowledge among peers, hone communication and presentation skills, and be evaluated by cohort members and instructors.

Course faculty members and the program coordinator will communicate with practicum students and preceptors regularly to assess progress and student-practicum site harmony, and to be available for problem resolution.

To facilitate your work, a program coordinator will focus on the following:

• Development, maintenance of and updating of affiliation agreements with practicum sites
• Student advising
• Development and maintenance of a student progress and practicum site evaluation data set
• Development and scheduling of mentoring encounters

To successfully complete the practicum, you must:

• Prepare periodic progress reports (to be submitted to the adviser)
• Deliver a presentation about their project to the class
• Prepare a final report to be submitted to and evaluated by the adviser. Length and format are per agreement with the adviser.