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[V7-S6] Paradigm Shift in Pharmacovigilance Activities - How to Conceptualize Research Questions -
Session Chair(s)
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)
Fit-For-Purpose Research Design in Pharmacovigilance Activities
Takuhiro Yamaguchi, PhD
Tohoku University Graduate School of Medicine, Japan
Professor, Biostatistics
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.
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