9th DIA Regulatory Communication Training Course in Japan
- Medical Writer, Associate Director
- PRA Health Sciences KK, Japan
Teruyo Arato, PhD
- Professor, Clinical Research and Medical Innovation Center
- Hokkaido University Hospital, Japan
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.
- Deputy Director
- Ministry of Health, Labour and Welfare (MHLW), Japan
Akiko Ikeda, RPh
- Associate Director, Regulatory Development Dept.
- Janssen Pharmaceutical K.K., Japan
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, PhD, RN
- Associate Director,Oncology Medical Science Department
- Daiichi Sankyo Company, Limited, Japan
Toshiko Ishibashi serves at Ono pharmaceutical company from 2018. She previously served at Abbvie as an Associate Clinical Operations Manager 2016-2018. She has experience as an assistant professor at 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.
- Senior Clinical Research Specialist
- MSD K.K., Japan
Yomei Matsuoka, MSc, RPh
- Vice President, Pharmacoepidemiology and PMS Department
- Daiichi Sankyo Co., Ltd., Japan
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.
Naomi Misaki, MPharm
- CRC, Research Management
- St. Luke's International Hospital, Japan
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.
- Duputy Review Director, Office of New Drug I
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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.
- Plus Action for Children, Japan
- Manager, R&D Regulatory 3, Regulatory Affairs
- Sanofi.K.K., Japan
Nao Tsuchida, MD, PhD
- National Hospital Organization Headquarters, Japan