Dr. Toshinori Higashi is a member of Regulatory Depelopment Department at Janssen Pharmaceutical K.K. In this position, Dr. Higashi is in charge of the contact work for negotiations with Helthcare Authorities (PMDA consultation, clinical trial notification, new drug application, etc.) for products under development. Dr. Higashi has experience in the pharmaceutical industries, Academia and PMDA, including pharmaceutical operations, and regulatory affairs. Dr. Higashi holds a PhD in Organic Chemistry from Keio University.

Dr. Akifumi Kamata is a reviewer of Office of Safety II in Pharmaceuticals and Medical Devices Agency (PMDA). In this position, Dr. Kamata is responsible for risk management and pharmacovigilance of vaccines, blood products and biosimilar products. Dr. Kamata has 9 years' experience in PMDA. Dr. Kamata holds a PhD in Pharmaceutical science from Tohoku University.

Japan Regulatory Portfolio Lead, Regulatory Strategy Group 3, Regulatory Strategy & Policy, Regulatory Affairs, Pfizer Japan Inc. Biography: I have worked for Pfizer since 2003. As a Japan Regulatory Lead, I worked on drug development (NDA/ PMDA consultation). I currently work on development drugs in Inflammation, Pain, CNS and Endocrinology as a Japan Regulatory Portfolio Lead. I received my bachelor and master degree in Pharmaceutical Science from Fukuoka University.

Mr. Yasutsugu Nakano is the section head of development regulatory affairs at Shionogi & Co., Ltd. Mr. Nakano has extensive experience in clinical development and medical writing, with approximately 15 years of experience in development regulatory affairs. Additionally, Mr. Nakano is a member of the Regulatory Affairs Committee at the Japan Pharmaceutical Manufacturers Association (JPMA) and serves as the leader of a task force that aims to identify issues for review reports and propose appropriate countermeasures to the Pharmaceuticals and Medical Devices Agency (PMDA). Mr. Nakano is also active as a member of the program committee for the DIA Regulatory Affairs Training Course.

Mr. Toshiki Sugita joined PMDA in 2008. He is in the Review Management Division, Office of Review Management.

Hiroyuki Murakami is currently deputy review director, Office of New Drug I, PMDA. He is engaged in a review of drugs for metabolic disorders including daibetes mellitus, inborn errors of metabolism, etc. He joined PMDA in 2006, and he served as a reviewer of gastrointestinal disease and kidney disease drugs for about 7 years. From 2013, he had been working as a risk manager of onclogy drugs in Office of Safety II. In 2017, he moved to current position.

Ms. Nobuko Ushirozawa is the Chief of the Research Administration Division at the National Cancer Center Japan (NCC). She oversees research fund management, ensures human reserch protection through the Research Ethics Committee, and supports industry-academia collaboration, enhancing NCC’s research promotion system. Starting her career as a nurse at a university hospital, Ushirozawa has spent 25 years supporting clinical research in various roles, including clinical research coordinator and establishing support organizations for investigator-initiated clinical trials. She also worked at the Ministry of Health, Labour and Welfare, promoting policies to revitalize clinical trials.