Yuka Nakatani (6th year, Faculty of Pharmacy, Department of Pharmacy *at the time)

I would like to talk about what I felt from participating in the 2019 Advanced Regulatory Science Training Program and how it connects to my current work.  

I want to contribute to providing safe and secure pharmacotherapy to patients around the world by delivering valuable pharmaceuticals and related information. I participated in this training program because I thought it would be a valuable opportunity to learn about pharmaceutical development from various perspectives and attitudes.  

During the training, we visited pharmaceutical companies, CROs, regulatory authorities, clinical trial sites, and Research Centers and Institutes. At each facility, they introduced us to pharmaceutical development and safety information management, such as post-marketing surveillance, in Japan, and we were able to learn about the differences with the United States through Q&A sessions. In addition to hearing about the initiatives at each facility, we had the opportunity to interact with interns and learn about the differences in pharmaceutical education. What impressed me most during this training was the concept of "Patient engagement." I felt that this is an approach that aims to improve public health by not only listening to patients' opinions and intentions and incorporating them into clinical trials, but also by disseminating information about treatment and health to patients and the general public to promote a correct understanding of medicine. Through this training, I have come to value the attitude of listening to patients' voices and want to maintain a "sincere passion" for delivering better pharmaceuticals and information to patients around the world.  

I am currently engaged in pharmacovigilance at a pharmaceutical company. In pharmacovigilance, to ensure patient safety, we collect and evaluate safety information and consider whether new risk concerns have arisen or if there is a need for alerts or information provision. We are involved not only post-marketing but also from the development stage, examining post-marketing safety surveillance activities and risk minimization measures. While the efficacy and risks of pharmaceuticals are two sides of the same coin, we have a mission to protect patient safety by monitoring the entire lifecycle of a drug, from development to post-marketing, disseminating necessary information, and maintaining the drug's benefit-risk balance.  

It has been about three years since I started working in pharmacovigilance, and whenever I was unsure about the evaluation policy for safety information or the consideration of countermeasures, the concept of "Patient Engagement" that I learned in this training has been my guiding principle. I make decisions after discussing internally, and sometimes consulting with physicians, about what perspective is best for confirming information and what impact it would have if this information were not delivered to medical sites and patients. Although I confirm safety information from a place somewhat distant from the clinical setting, I must not forget that all my work is for ensuring patient safety.  

I feel that there is a current situation where we cannot fully grasp whether the information we want to convey is reaching and being understood by medical professionals and patients, or whether it is leading to behavioral changes for the proper use of pharmaceuticals. I personally believe that the solution to this is to listen carefully to the voices of medical professionals and patients and to solve it by treating patients as members of the team. "Patient Engagement" seems like a new concept, but I feel it is a fundamental and important idea that emphasizes two-way communication, meaning it should not be one-sided communication from the pharmaceutical company. I want to continue to deliver information that supports the lives of patients and those around them, keeping the concept of Patient Engagement in mind.  

I felt that this training was a valuable opportunity to perceive from multiple angles the important ways of thinking and attitudes in providing medical care, not just in pharmaceutical development. It is rare to have the chance to visit so many facilities at once, and if you are hesitant to participate, I strongly encourage you to take the leap and join. I am sure you will gain something that will become an important anchor for you even after you become a working professional.  

I would like to express my deepest gratitude to the people at the companies and facilities who taught us so much during this training, and to the professors at Keio University who provided this valuable opportunity.