9th DIA Project Management Training Course in Japan
Noriko Fujiwara, MS, RN
- Research Nurse, Project Researcher, Department of Palliative Medicine
- IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Japan
Ms. Noriko Fujiwara is a research nurse and a project researcher of the department of palliative medicine, the Institute of Medical Science, the University of Tokyo. She has over 10 years' experience in research field. She is a Certified Nurse Specialist in Cancer Nursing with the Japanese Nursing Association and a Certified Clinical Research Professional with the SoCRA. She completed the Project Management Certification Program in UCSD, CA, USA, and research internship at MD Anderson Cancer Center, TX, USA. She is currently a president of the Japan chapter of the International Association of Clinical Research Nurses.
Yasuo Fukushima, PhD
- Associate Director, Group III,
- Daiichi Sankyo Co., Ltd., Japan
Koji Iwasaki, PhD
- Professor, Academic Clinical Research Center,
- Osaka University Hospital, Japan
Dr.Koji Iwasaki is the Professor of Academic Clinical Research Center, Osaka University Hospital. Dr. Iwasaki is incharge of progress of clinical research, specially, building the strategy, clarify the hypothesis and creating the protocol for clinical trial with investigators in reserch team. Dr. Iwasaki has over 30 years' clinical development experience in the pharmaceutical company, including clinical research and reguratory science. Dr. Iwasaki holds a PhD in Pharmaceutical science from Kyoto Pharmaceutical University.
Koichi Konno, PMP
- Chief Executive
- PM Consulting Positive Intention, Japan
Noriaki Nagao, MPharm, PMP
- Director, Quality Control Team Leader, Clinical Development Dept.
- Japan Tobacco Inc., Japan
Mr. Noriaki Nagao is Clinical Quality Management Team Leader at Clinical Development Dept. Pharmaceutical Division JAPAN TOBACCO INC. In this position, Mr. Nagao is responsible for keeping and managing quality of conducting clinical trials in this organization, including GCP training , document management, document check, and SOP management and so on. Mr. Nagao has 16 year' experience in the Pharmaceutical industry, including CRA and quality management. Mr. Nagao holds a PMP certified by Project Management Institute, and holds a MPharm in Tokyo University of Pharmacy and Life Sciences.
Takashi Sato, MSc, PMP
- Manager, Resource Management Group, R&D Planning Department
- Kyowa Kirin Co., Ltd., Japan
Takashi Sato is Team Leader of R&D Planning Department, R&D Division, Kyowa Hakko Kirin Co., Ltd. He serves as the project manager for development of several new pharmaceuticals and leader of Project Management Office from 2018. Prior to these works, he has been the project manager for renewal projects of electric document management systems and their system management for 6 years, and the project manager for new pharmaceuticals for 9 years. He also has work experience as a CRA, and as a pharmacovigilance specialist in clinical studies. Takashi Sato is Project Management Professional certified by Project Management Institute. Also, he is Certified Professional Co-active Coach by Coach Training Institute.
Shuji Sumida, MSc, RPh
- Senior Specialist, Business Strategy & Compliance Department
- Chugai Pharmaceutical Co., Ltd., Japan
Shuji Sumida serves as Manager of the Business Strategy and Compliance Department at Chugai Pharmaceutical Co., Ltd., responsible for oversight of Chugai’s GxP Compliance and Quality Management Systems. Mr. Sumida has more than three decades of pharmaceutical industry experience including formulation technology, project management, and quality and regulatory compliance. He earned his MSc in Pharmacoscience from Tokyo University of Science, and is a registered pharmacist.
Atsushi Tsukamoto, PhD, MSc
- Vice President, New Drug Regulatory Affairs
- Daiichi Sankyo Co., Ltd., Japan
Atsushi is VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He is also Head of Specialty Medicine RA in R&D division, to lead gobal specialty medicine regulatory strategies. As Head of Japan New Drug RA, he is responsible for leading new drug RA activities for all projects (RA strategy & operation). He has been global project manager for nearly 20 years (in JPN & US) and the head of PM office in Daiichi Sankyo Japan for 3 years. He has been an active volunteer to both DIA global and Japan, playing session chair roles in global annual meeting more than 10 times, and was the vice-chair for 13th DIA Japan Annnual Meeting 2016. He holds PhD in Drug Development from Kitasato Univ and is the receipent of DIA outstanding award in 2014.