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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)
Risk Communication: From Consumers’ Perspective
Kyoko Kitazawa, MSc
Healthcare Journalist (Kyoto Pharmaceutical University), Japan
Visiting Professor
Risk Communication: A Company Perspective
Shinichi Nishiuma, MD
Aculys Pharma Inc,, Japan
Executive officer, Chief Medical Officer
Xavier Luria, MD
(DDR) Drug Development and Regulation, Spain
Chair and Senior Consultant
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