Courses

This course provides a basic understanding of the analysis of data to identify safety signals and to determine a product's risk profile to ensure a medical product has a favorable benefit-risk balance through its life cycle. Topics include the rationale and methods used in analyzing single cases versus aggregate data. Upon completion, students should be able to synthesize work in case processing, safety systems, safety reporting and regulations to assess a product's benefit-risk, as well as to identify the issues in ongoing benefit-risk assessments and demonstrate a basic understanding of how signaling and risk assessments are done.

The following courses must be completed prior to taking this course:
Must complete MSP-130 with minimum grade C