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[V8-S6] Approaches to Implement Revision for New Format Labeling and Discussion How to Provide Information by Other Materials
Session Chair(s)
Takashi Ohira
Associate Director, Safety Management, Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, Japan
In April 2019 official guidelines for new format of labeling will be enforced. Prior to that, PMDA consultation with some drugs to align with the new guidelines was started from July this year (first wave), and feedback from PMDA has been notified each company. Based on the disclosure of labeling of some model drugs, we introduce examples of them and discuss case studies and initiatives concerning tasks until actual implementation of revision of the labeling of the new guideline. Also, we would like to discuss contrivances in thinking about effective information provision with other materials such as interview form based on new format of labeling, and viewpoints from healthcare providers as readers of new format of labeling and points to note when providing information.
Speaker(s)
Akifumi Kamata, PHD
Office of New Drug I, Pharmaceuticals and Medical Devices Agency, Japan
Official Guidelines for New Format of Labeling and Findings of First Wave of Consultation for Labelling Revision
Tatsumi Inamura
Group Manager, Prescribing Information Group, RA Functions Department, Novartis Pharma K.K., Japan
Provision of Approaches to Implement Revision for New Format of Labeling from the Pharmaceutical Industry Perspective
Hideo Nakada, RPH
Deputy Associate Manager, Department of Hospital Pharmacy, Keio University, Japan
Provision of Approaches to Implement Revision for New Format of Labeling from Pharmacist of Medical Institute Perspective
Shinya Takemoto, MSC
Group Manager, Safety Information Strategy Group, Risk Communication Department, Chugai Pharmaceutical Co., Ltd., Japan
Provision with Other Materials such as Interview Form based on New Format of Labeling and Providing Information