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[V3-S6] Risk Communication in EU, US and Japan - Goals and Objectives of Various Tools including Labeling - (Part 2)
Session Chair(s)
Rei Maeda
Consultant, Independent Consultant for Drug PV, Japan
Shinobu Uzu, PhD
Senior Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
USPI, SmPC and Japan Package Insert are the fundamental tools for effective risk communication, with limited space. In addition, various tools for risk communication like medication guides for patients have been developed and utilized. In this session, the current risk communication strategies of FDA, EMA and MHLW/PMDA will be presented. Challenges and possible solutions for current tools will be presented from the view of health care professionals followed by a panel discussion for the future of risk communication.
Speaker(s)
Kyoko Kitazawa, MSc
Visiting Professor, Healthcare Journalist (Kyoto Pharmaceutical University), Japan
Risk Communication: From Consumers’ Perspective
Shinichi Nishiuma, MD
CEO, Nishiuma Inc., Japan
Risk Communication: A Company Perspective
Xavier Luria, MD
Chair and Senior Consultant, (DDR) Drug Development and Regulation, Spain
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