Yoshikata Furuya was Director of Vaccine Policy at MSD K.K. In this position, he was responsible for developing and executing policy strategies and action plan for MSD vaccines. Yoshikata Furuya had over 25 years' experience in the pharmaceutical and biotech industries including marketing, regulatory affairs and health policy.

She graduated Hokkaido University faculty of Pharmacy in1984 and received her Ph.D. in Medicine from the University of Tokyo in 1998. She joined the Pharmaceuticals and Medical Devices Evaluation Center, National Institute of Health Sciences (Japan) in 1999. From 2005 to 2011, she was a Review Director, Office of Biologics, PMDA (Pharmaceuticals and Medical Devices Agency) . She served as the Division Director of Human Resources Development Division, Office of Regulatory Science, PMDA from 2011-2012. She is currently working as a Professor of Hokkaido University Graduate School of Medicine. She is also a member of the Health Science Council of Ministry of Health, Labour and Welfare (MHLW) and outside expert of PMDA.

Mr. Katsuhiko Ichimaru currently serves as Review Director in Office of New Drug IV in Pharmaceuticals and Medical Devices Agency (PMDA). He graduated from Faculty of Tokushima University graduate school of Pharmaceutical science in 2000. He joined Pharmaceuticals and Medical Devices Evaluation Center of National Institute of Health Science (PMDEC), the predecessor of PMDA, in 2002 and continues his career on drug review in PMDA since April 2004. He was engaged in a review of central or peripheral nervous system drugs, antibacterial drugs and antiviral drugs, review management and MID-NET operation and management.

Education Background: Graduated Tokyo University of Pharmacy and Life Sciences / Qualification: Licensed Pharmacist / CURRENT POSITION: Senior Manager of Policy Intelligence Department in Janssen Pharma K.K (Japan), A leader of Regulatory Sub Committee in PhRMA Japan, A member of Contents Committee in DIA Japan / SUMMARY OF PROFESSIONAL EXPERIENCE: 5 years of experiences at regulatory policy and intelligence; About 20 years of experiences at regulatory affair area including development for New drugs (NDA/ PMDA consultation); Started the carrier at Sankyo Co. (Currently Daiichi-Sankyo Co.) in 1986.

Toshiko Ishibashi is an Associate Director of Oncology Medical Science in Medical Affairs at Daiichi Sankyo Co., LTD. since 2020. She served Ono Pharmaceutical Company from 2018 to 2020. She was a Clinical Operations Manager at Abbvie, 2016-2018. She has experience as an assistant professor at the College of Nursing Art and Science, University of Hyogo. She has 16 years of clinical research experience as a Clinical Research Coordinator at Kumamoto University Hospital and St. Luke’s International Hospital.

Dr. Tetsunari Kihira is Office Director of Office of Vaccines and Blood Products at PMDA. In this position, Dr. Kihira is responsible for IND/NDA review of vaccines against infectious diseases and blood products. Dr. Kihira joined MHW (current MHLW) in 1995, and has experience in new drugs review, policy making of pharmaceutical affairs, medical service and dispensing fee revision and drug pricing at MHLW. Dr. Kihira has also experience in temporary transfer to Science and Technology Agency, PMDA, Toyama prefectural government and visiting fellow at U.S. FDA.

Mr. Matsuoka is Senior Director of Pharmacovigulance Department at Daiichi Sankyo Co., LTD. He joined Sankyo Co., LTD. in 1991, and has worked for Daiichi Sankyo Co., LTD.since 2007. After engagement in clinical development department and regulatory affairs department for over 20 years, and moved to pharmacovigilancedepartment. Currently, he is in charge of safety planning for the several therapeutic areas such as CV, oncology, CNS, vaccines and contrast agents.

Ms. Misaki is a manager of a research management at St.Luke's Inernational Hospital. In this position, Ms. Misaki is responsible for managing all clinical trials, IRB and research committees in the hospital. Ms. Misaki also supports research planning in the hospital. Ms. Misaki has 20 years' of experience as a CRC and as a secretary member of the IRB and Research Ethics Review Board.

Kyohei Shintaku joined Pfizer Japan Inc. in 2006 after obtaining Master degree in Graduate School of Pharmaceutical Sciences from Kyushu University. He started his career as a scientist of Pharmacodynamics and Drug Metabolism. He moved to Regulatory Affairs and serves as a Japan regulatory strategist for a lot of projects from development phase to post-marketing phase. He joined DIA Japan Operation Team (OT) in 2014 and supported various DIA Japan events including Advanced Regulatory Training Course, Labeling Workshop. He contributed to the increase of OT in DIA Japan. He served as Vice-chair support for 15th Japan Annual Meeting, leading to a great success of the event. We expect that he will continue contributing to DIA activities.