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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V7-S6] Paradigm Shift in Pharmacovigilance Activities - How to Conceptualize Research Questions -

Session Chair(s)

Rei  Maeda

Rei Maeda


Independent Consultant for Drug PV, Japan

“Review on planning of post-marketing surveillance” released from the PMDA in January this year is significantly changing the approach to conducting a review of pharmacovigilance. It is important to clarify research questions beforehand based on the information from clinical trials and target diseases as well as the characteristics of medicinal products, after which point pharmacovigilance activities can be conducted sufficiently and appropriately. This session will focus on and discuss how to consider clinical questions and link them with clear research questions.


Takuhiro  Yamaguchi, PhD

Fit-For-Purpose Research Design in Pharmacovigilance Activities

Takuhiro Yamaguchi, PhD

Tohoku University Graduate School of Medicine, Japan

Professor, Biostatistics

Sayuri  Nakane, MHS

Current Situation and Challenges of Pharmacoepidemiology and Data Utilization in Pharmaceutical Companies

Sayuri Nakane, MHS

Chugai Pharmaceutical Co., Ltd., Japan

PMS Data Management Group, Real World Data Science Dept., Drug Safety Div.

Chieko  Ishiguro, PhD, MPH

Clinical & Research Question in Pharmacovigilance Planning

Chieko Ishiguro, PhD, MPH

National Center for Global Health and Medicine, Japan

Section Chief of Clinical Epidemiology, Department of Data Science