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[V3-S5] Risk Communication in EU, US and Japan - Goals and Objectives of Various Tools including Labeling - (Part 1)
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)
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
The Impact of Risk Communication
Giampiero Mazzaglia, MD, PhD, MSc
Associate Professor of Hygiene and Public Health, University of Milan, Italy
Risk Minimisation Measures in The EU: Communication, Implementation Challenges and Methods for Impact Assessment <Prerecorded Presentation>
Mayumi Torii
Office of Safety l, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Awareness and Utilization of Risk Communication Tools in Medical Institutions
Hiroyuki Furukawa, PhD
Professor, Phamarcy Service, Graduate School of Yamaguchi University, Japan
This is the important role for pharmacists to Protect patients from risk of medicine !
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