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[S15] Lessens from Experiences Using MidNet for PV
Session Chair(s)
Yoshiaki Uyama, PhD, RPh
Associate Executive Director
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)
Overview of Utilization of MID-NET
Katsuhiko Ichimaru
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Review Director, Office of New Drug IV
Practice of MID-NET Use in Post-Marketing Database Study
Kei Sagawa
Daiichi Sankyo Co., Ltd., Japan
Pharmacovigilance, Safety and Risk Management Department
Utilization of MID-NET from Pharmacovigilance Perspective
Makoto Miyazaki, MSc
Japan Pharmaceutical Manufacturers Association (JPMA) / MSD K.K. , Japan
Recommendations on Feasibility Assessment to Leverage MID-NET
Shintaro Hiro, PhD
Pfizer R&D Japan, Japan
Manager, Data Science & Analytics Japan Lead, Clinical Statistics