A case study of regulatory science education at Ritsumeikan University with mock drug reviews

Abstract

The regulatory science education at Ritsumeikan University includes approving mock drug reviews in their Introduction to Clinical Studies course (a total of 8 classes). In 2018, the first year of this course, the students divided into reviewer and applicant groups for discussions with the names of the review products disclosed beforehand. Some issues that resulted from this activity were: (1) the results of the drug review were similar to the review reports by PMDA, (2) the presentations became redundant because they did not narrow down the main points, and (3) the different roles of reviewer and applicant were not fully utilized. To improve this learning method in 2019, 70 senior students were provided with the basic drug information and summaries of clinical studies for two approved anti-influenza viral agents. The drug names were not disclosed, and the information was obtained from the PMDA’s ethical pharmaceutical information search website. Students were divided into two groups to approve or deny each drug to improve logical thinking ability and to stimulate discussion. The outcome was that they debated actively, and each group successfully presented the collated review results within the time limits. Our objective is to continue improving on this learning method with these mock drug reviews.