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[S24] Have You Already Had a Labeling with New Format? How to Read New Format of Labeling and Impact for Implementation on Medical Practice
Session Chair(s)
Hideo Nakada, RPh
Deputy Associate Manager, Department of Hospital Pharmacy
Keio University, Japan
In April 2019, the official guidelines for the new labeling format came into force, and certain specific products with labeling in line with these new guidelines have actually begun to reach the medical field. This session will present practical examples of actions taken by pharmaceutical companies in response to these guidelines, their impact on other materials (interview forms, etc.), the impact of delivering products with labeling in this new format, and points to consider when reading labeling in this new format. We will also discuss how information should be disseminated and how to provide information to advance use of the new labeling format in future medical practice.
Speaker(s)
Points of New Format of Labeling and Impact on Other Materials
Natsumi Kinoshita
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of Conformity Audit
Company Initiatives in Delivery of Labeling with New Format to Medical Practice
Naoto Tone
Eli Lilly Japan K.K., Japan
Regulatory Scientist, Regulatory
Impact for Delivery of Labeling with New Format on Medical Practice from Pharmacists of Medical Institute Perspective
Yuuki Sasaki
Nihon University Hospital, Japan
Chief, Pharmaceutical Department
Impact of New Format PI for Other Materials
Yukio Ikejima
Eisai Co., Ltd., Japan
Japan and Asia Pharmacovigilance Department, CMA HQ