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[V4-S2] How to Read and Future Prospects for PMDA Review Reports
Session Chair(s)
Mamoru Narukawa, PhD, RPh
Professor, Department of Clinical Medicine (Pharmaceutical Medicine)
Kitasato University School of Pharmacy , 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)
Review Reports - Introduction and Future Perspectives
Mamoru Narukawa, PhD, RPh
Kitasato University School of Pharmacy , Japan
Professor, Department of Clinical Medicine (Pharmaceutical Medicine)
Utilization of Review Reports in Clinical Setting
Mayumi Mochizuki, PhD
Keio University, Japan
Professor Emeritus
Utilization of Review Reports for Safe/Successful Launch of New Drugs
Fusako Oura, PhD
MSD K.K., Japan
Pricing Group, Market Access
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
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