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[S15] Lessens from Experiences Using MidNet for PV
Session Chair(s)
Yoshiaki Uyama, PHD, MS, RPH
Associate Executive Director, Regulatory Science Center, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
So far, there have been three cases of the use of MID-NET, a government-owned database which has become available since April 2018. These three companies are invited to talk about their experience of using MID-MET from various perspectives such as data accumulation, data analysis, information delivery and discuss issues in using the database. In the panel, a representative of MID-NET devision of PMDA will also invited and the future perspective of the utilization of MID-NET for pharmacovigilance as well as the issues to overcome for a full utilization of the database.
Speaker(s)
Katsuhiko Ichimaru
Review Director, Office of New Drug IV, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Overview of Utilization of MID-NET
Kei Sagawa
Pharmacovigilance, Safety and Risk Management Department, Daiichi Sankyo Co., Ltd., Japan
Practice of MID-NET Use in Post-Marketing Database Study
Makoto Miyazaki, MSC
, Japan Pharmaceutical Manufacturers Association (JPMA) / MSD K.K. , Japan
Utilization of MID-NET from Pharmacovigilance Perspective
Shintaro Hiro, PHD
Manager, Data Science & Analytics Japan Lead, Clinical Statistics, Pfizer R&D Japan, Japan
Recommendations on Feasibility Assessment to Leverage MID-NET