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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)
Takuhiro Yamaguchi, PHD
Professor, Biostatistics, Tohoku University Graduate School of Medicine, Japan
Fit-For-Purpose Research Design in Pharmacovigilance Activities
Sayuri Nakane, MHS
PMS Data Management Group, Real World Data Science Dept., Drug Safety Div., Chugai Pharmaceutical Co., Ltd., Japan
Current Situation and Challenges of Pharmacoepidemiology and Data Utilization in Pharmaceutical Companies
Chieko Ishiguro, PHD, MPH
Section Chief of Clinical Epidemiology, Department of Data Science, National Center for Global Health and Medicine, Japan
Clinical & Research Question in Pharmacovigilance Planning