US Food and Drug Administration (FDA) Yuki Namba (6th-year student, Department of Pharmacy, Faculty of Pharmacy *at the time)

On behalf of the Keio University Faculty of Pharmacy, I participated in an FDA training program in 2018. During the approximately one-month training period, I primarily learned about the drug development and review process in the United States and the mechanism by which the FDA provides information to patients, healthcare professionals, and companies. Specifically, I assisted with telephone support for adverse event reporting, participated in public hearings related to drug development, attended lectures for pharmacy students by FDA officials, gave a journal club presentation on the theme of clinical trials for new drugs, and delivered a presentation on Japan's approval system and post-marketing surveillance. I also engaged in daily, highly specialized discussions in business and science on an equal footing with American pharmacy students. Through discussions with students from completely different backgrounds, I was able to gain many insights arising from differences in culture and perspective. At the same time, I had a stimulating time expressing my opinions in English from my own point of view and engaging in discussions.

As I had decided to enter the world of new drug development after graduating from university, I was convinced even at that time that the FDA training, which allowed me to experience drug development from a regulatory authority's perspective, would be a major advantage for my future career. And now, I am actually involved in new drug development from the business side. The valuable experience from the FDA training has become a very important benchmark for considering my role in drug development and my career prospects from a bird's-eye view.  

On behalf of Keio University Faculty of Pharmacy, I participated in the Food and Drug Administration (FDA) Pharmacy Student Experiential Program in 2018. Through the training period of about a month, I mainly learned about the "drug development and review processes in the United States (US)" and "how the FDA provides information to patients, healthcare professionals, and the industry."

Specifically, I experienced: shadowing of adverse event report calls, participating in public meetings related to drug development, student lectures offered by FDA staffs, Journal Club presentation of an article about a study of recent FDA approved drug, and a presentation about the approval system and post-approval assessment in Japan. In addition, with the US pharmacy students, I had discussions about highly specialized topics of business and science every day. Through discussions with students from completely different backgrounds, I had a lot to learn from the differences in culture and perspectives. At the same time, I had an exciting time to express my opinions in English from my own perspective.

For me, who had decided to join the industry of drug development after graduating from university, I was convinced from that time that this FDA program, which gives me exposure to drug development from a regulatory perspective, would be a great advantage for my future career. And now I am actually involved in drug development from the business side. These valuable experiences in the FDA program are now a very important indicator for me, in terms of understanding my role in the drug development industry and deciding my career plans from a wider point of view.