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.

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.

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.

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.

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.