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東京ビッグサイト | 有明

2018年11月11日 (日) 午前 9:30 - 2018年11月13日 (火) 午後 5:40

〒135-0063, 東京都江東区有明3-11-1



[V4-S2] How to Read and Future Prospects for PMDA Review Reports

Session Chair(s)

Mamoru  Narukawa, PhD, RPh

Mamoru Narukawa, PhD, RPh

Professor,Graduate School of Pharmaceutical Sciences

Kitasato University, Japan

PMDA review report of similar drugs is a very useful reference for considering development strategies. The tips of reading PMDA review report will be introduced as the short presentation of “point of the innovative drug supply review” author. Following this, pharmacists will opinion with them how they are using the review report in the HCPs. Pharmaceutical will explain how to use review report for development strategies (including the perspective of drug price negotiations) and future expectations. Additionally, PMDA will show the previous initiatives and future prospects.


Mamoru  Narukawa, PhD, RPh

Review Reports - Introduction and Future Perspectives

Mamoru Narukawa, PhD, RPh

Kitasato University, Japan

Professor,Graduate School of Pharmaceutical Sciences

Mayumi  Mochizuki, PhD

Utilization of Review Reports in Clinical Setting

Mayumi Mochizuki, PhD

Keio University, Japan

Professor Emeritus

Fusako  Oura, PhD

Utilization of Review Reports for Safe/Successful Launch of New Drugs

Fusako Oura, PhD

MSD K.K., Japan

Pricing Group, Market Access

Hiroyuki  Murakami

Current Situation and Future Prospects of PMDA Review Reports

Hiroyuki Murakami

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Duputy Review Director, Office of New Drug I