9th DIA Project Management Training Course in Japan
Noriko Fujiwara, MS, RN
- Project Researcher, Oncology nurse
- IMSUT Hospital, The Institute of Medical Science, The University of Tokyo, Japan
Ms.Noriko Fujiwara, MS,RN,OCNS,CCRP works as a research nurse and a project researcher for the department of palliative medicine and advanced clinical oncology, IMSUT hospital of the Institute of Medical Science, the University of Tokyo, JAPAN. She completed the Project Management Certification Program at UCSD, CA, USA in 2016, and a 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 (IACRN), a member of the Research Nurse Committee of Gynecologic Oncology Trial and Investigation Consortium (GOTIC), and an operational chair of Asia-Pacific Gynecologic Oncology Trials group (APGOT).
Yasuo Fukushima, PhD, MBA
- Daiichi Sankyo, United States
Dr. Yasuo Fukushima is a project manager of new drug developmen at Daiichi Sankyo Inc., and responsible for global drug development of a antibody-drug conjucate for cancer treatment. His background is Ph.D. for pharmaceutical science, and he has over 20 years of experience in the company for drug discovery research and project management (located in Japan and USA) in early- & late-stage projects having various drug modalities such as small molecules, biologics, and nucleic acid, or alliance programs with extenal parties. He also holds a Master degree for Business Administration, and a Certificate for Project Management Specialist of Program & Project Management. He is a member of DIA PM Community.
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 has experience in setting up medical affairs departments in pharmaceutical companies and he is the organizer of the Medical Affairs Certification Training Program of the Regulatory Science Foundation. Dr. Iwasaki holds a PhD in Pharmaceutical science from Kyoto Pharmaceutical University.
Koichi Konno, PMP
- Chief Executive
- PM Consulting Positive Intention, Japan
Mr. Koichi Konno is a chief executive at PM consulting Positive Intention. Mr. Konno has started his career as a consultant of project management in 2013. He has over ten years of experience as a manager of PMO, after 10 years of working as a leader of clinical study in a pharmaceutical company. Mr. Konno holds certification of Project Management Professional (PMP) and he is a lead of Project Management Community of DIA Japan.
Noriaki Nagao, MPharm, PMP
- Clinical Development Dept. Pharmaceutical Division
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
- PM Orchestra Takashi Sato, Japan
<p>Takashi Sato has worked in research and development division of a pharmaceutical company for more than 30 years, and currently belongs to the planning and development function. Before these works, he led Project Management Office and had work experience in Clinical Operations, and as a pharmacovigilance specialist in clinical studies.</p> <p>Besides his works in the company, he run his private business since 2021. He serves training for project management, consultations, and coaching in his business. Takashi Sato is Project Management Professional certified by Project Management Institute. Also, he is a Certified Professional Co-active Coach by Coach Training Institute. </p>
Shuji Sumida, MSc, RPh
- Senior Director, Quality & Regulatory Compliance Unit
- Chugai Pharmaceutical Co., Ltd., Japan
Mr. Shuji Sumida is Senior Director, HR Business Partner of Quality & Regulatory Compliance Unit at CHUGAI PHARMACEUTICAL CO., LTD. In this position, Mr. Sumida is a responsible person for HR strategy containing hiring, rotation and carrier development in that division. Mr. Sumida has over 35 years' experience in the pharmaceutical industries, including Formulation Technology, Project Management, and Quality & Regulatory Compliance. Mr. Sumida holds a MSc in Pharmacoscience from Tokyo University of Science and a Project Management Specialist from PMAJ.
Atsushi Tsukamoto, PhD, MSc
- Vice President, New Drug Regulatory Affairs Department
- Daiichi Sankyo , 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.