Advanced Regulatory Science International Practicum

The purpose of this program is to cultivate individuals who can proactively lead the future with courage, equipped with a foundation and broad perspective in international drug development and regulatory science. To achieve this, jitsugaku (science) training will be conducted at various institutions involved in the practice of drug development and regulatory science in the United States and elsewhere. Becoming a leader requires the ability to engage in high-level discussions, multidisciplinary knowledge, and curiosity. Acquiring these skills is best achieved by venturing out into the world to see and experience things firsthand. This program aims to accomplish this through training in the United States, a forerunner in the field of pharmaceutical sciences.

To achieve the above purpose, participants will visit universities such as Harvard University, companies like IQVIA and Pfizer Inc. headquarters, and government agencies including the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH)Research Centers and Institutes. This is a practical training program for which participants will undertake preliminary studies in areas such as language and international drug development and decide on their research themes in advance. According to students who have participated in this practicum, discussions on medical issues in Japan and the U.S. with leading experts and local students from diverse backgrounds were highly stimulating. The experience gained from this program will undoubtedly contribute not only to their own post-graduation careers but also to Japan and, by extension, the world.

Students who apply for this program and are selected will register for the following courses:

Sixth-year Department of Pharmacy students: Elective course "Advanced Regulatory Science International Practicum" (1 credit)

Students in the Doctoral Programs in Pharmaceutical Sciences, Major in Pharmaceutical SciencesPh.D. program, and Master's Program: Elective course "Special Training in International Regulatory Science" (1 credit)

Faculty of Pharmacy faculty members

6 students (planned)

The program consists of an approximately 12-day training period in the United States, during which participants will visit institutions such as Harvard University, Pfizer Inc. headquarters, and the U.S. Food and Drug Administration. Additionally, about two preparatory lectures will be held. After attending lectures on topics including international pharmaceutical regulations and ICH, Japan's Pharmaceutical Affairs Act, regulatory agencies like the U.S. FDA, and strategies of global companies, participants will identify issues in the international pharmaceutical environment and Japan, and then decide on their research themes for the U.S. training. After returning to Japan, a debriefing session will be held on campus in December.

Total costs are approximately 400,000 JPY, covering airfare, local transportation, accommodation, ESTA application fees, overseas travel insurance, and other expenses.

As a general rule, applicants must have an English proficiency level equivalent to a TOEFL iBT score of 70 or higher, or a TOEIC score of 750 or higher (or a comparable score from another standardized English proficiency test) at the time of application. To apply, students must submit an application form, a copy of their TOEIC Official Score Certificate (or a certificate from a comparable English proficiency test), and a copy of their most recent academic transcript. An initial screening will be conducted based on the submitted documents. Candidates who pass the initial screening will proceed to a second screening (interview).

Application deadline: Mid-February. Announcement of participants: Late February.

Domestic preliminary training from April to June.

US training program from mid- to late July.

Joint practical training debriefing session around December.

Attitude during practical training (50%), participation in preparatory lectures (20%), and presentation and report (30%).