2021 Volume 11 Issue 2 Pages 125-129
In regulatory science (RS), as proposed by Dr. Uchiyama in 1987, many instructors are engaged in education in diverse subject areas in pharmacy schools. However, since RS was incorporated into the model core curriculum of pharmacy education and its importance became recognized, various interpretations have been made, being problematic. It has recently become required in the syllabus to clarify the class subjects taught by faculty with working experience. The staff of Ministry of Health, Labor and Welfare, and Pharmaceuticals and Medical Devises Agency, move to the education site as a scholar-practitioner with working experience, and cases in which they host their own laboratory as a professor of drug evaluation, and regulatory science, have been increasing. The method of RS, in which the results are predicted from acquired data and evaluated, leading to, may be acquired by pharmacy students. Various education methods are executed by scholar-practitioners to foster their RS-related problem-solving ability by applying active learning. The adjustment and evaluation abilities acquired at university are important for not only pharmacy school graduates engaged in drug development, manufacturing, and supply, but also pharmacists. For example, pharmacy school graduates are expected to find RS-based patient-oriented solutions through learning about the substantiation of information obtained from regulatory authorities by experiencing the simulation of evaluation for new drug approval at university. It is also important to clarify the responses of the regulatory authority and provide the evidence for these to students in RS education that the evidence for the evaluation made by regulatory authority changes depending on the state of data accumulation.
