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[V4-S2] How to Read and Future Prospects for PMDA Review Reports
Session Chair(s)
Mamoru Narukawa, PHD, RPH
Professor, 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.
Speaker(s)
Mamoru Narukawa, PHD, RPH
Professor, Kitasato University, Japan
Review Reports - Introduction and Future Perspectives
Mayumi Mochizuki, PHD
Professor Emeritus, Keio University, Japan
Utilization of Review Reports in Clinical Setting
Fusako Oura, PHD
Pricing Group, Market Access, MSD K.K., Japan
Utilization of Review Reports for Safe/Successful Launch of New Drugs
Hiroyuki Murakami, PHD
Duputy Review Director, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Current Situation and Future Prospects of PMDA Review Reports