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Tokyo Big Sight

11 nov 2018 9:30 a.m. - 13 nov 2018 5:40 p.m.

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

15th DIA Japan Annual Meeting 2018

Innovative technologies such as AI, big data/genomics, and cell/gene therapies are poised to transform healthcare product development across the globe – join us to discuss these topics.

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

Session Chair(s)

Rei  Maeda

Rei Maeda

Consultant

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.

Speaker(s)

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

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