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#5: Fundamental Knowledge of Project Risk Management for Medicinal Product Development

Nov 6 2013 11:00AM - Nov 6 2013 12:45PM | TFT Halls & Rooms TFT Building, 3-6-11 Ariake, Koto-ku, Tokyo 135-8071 Japan

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Overview 

Registration is now closed for this Tutorial.


Session Chairs
Shuji Sumida
Group Manager, Quality & Regulatory Compliance Unit
Chugai Pharmaceutical Co., Ltd.

Koichi Konno, PMP
Chief Executive, PM Consulting Positive Intention

Due to the high uncertainty, also the low probability of success in the pharmaceutical R&D, Project RISK Management (PRM) is important to provide basics to manage uncertainty of projects. It is a management approach to RISK which may impact the goals of the project “Timeline”, “Deliverables” and “Resources”, etc. The importance of PRM is becoming higher in the R&D especially for innovative new drugs to satisfy unmet needs. This session introduce basic approach of qualitative and quantitative RISK analysis at project start-up, then after conducting the excise of RISK identification and response planning, the way of communication with executives on the RISK will be also discussed. It will be also discussed where is the common points with the Risk Management Plan which is mandated from this year to submit with NDA in Japan. First steps of PRM are visualization of RISK, necessary preparation (mitigation plans and contingency plan), then initiation of project.

Lecturers
Katsumi Yamamoto, PMP
Associate Director/East Asia Keppra Lifecycle Leader,
Development East Asia & Network, UCB Japan Co., Ltd.

Koichi Konno, PMP
Chief Executive, PM Consulting Positive Intention

Shuji Sumida
Group Manager, Quality & Regulatory Compliance Unit,
Chugai Pharmaceutical Co., Ltd.

Contact Information 

DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku,
Tokyo 106-0041 Japan
Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAjapan@diajapan.org

Instructor(s) 

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