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[V2-S5] For RMP That can be Utilized by Healthcare Professionals
Session Chair(s)
Kazuhiko Ishida, MSC, RPH
Director, Pharmacovigilance, Astellas Pharma Inc., Japan
PMDA and AMED study results show that “awareness of RMP” among healthcare professionals (particularly hospital pharmacists) and “utilization of RMP for pharmacy operations in medical institutions” have been increasing every year. Meanwhile, many of the companies preparing RMP consider RMP only as documents to be submitted to the regulatory authority. In these situations, some hospital pharmacists say that many points of the current RMP are difficult to understand and use for pharmacy operations at medical institutions in terms of naming risks or reasons of setting. We will discuss what healthcare professionals expect from RMP and how companies and the regulatory authority should respond to expectations from healthcare professionals when we think about the utilization of RMP for pharmacy operations at medical institutions.
Speaker(s)
Masahiro Hayashi, PHD
Pharmaceutical affairs specialist, Department of Pharmacy, Toranomon Hospital, Japan
Current Status of RMP Utilization in Hospitals and Recommendations for RMP - Based on AMED Research Narukawa Team Results
Taku Obara, PHD
Associate Professor, Tohoku University Graduate School of Medicine,, Tohoku University Hospital, Japan
RMP Utilization for ADR Reporting in the Community Health Care Setting
Shinya Takemoto, MSC
Group Manager, Safety Information Strategy Group, Risk Communication Department, Chugai Pharmaceutical Co., Ltd., Japan
Pharmaceutical Company’s Approach for the Usage of Risk Management Plan (RMP) in Medical Settings
Yusuke Matsunaga, PHD
Reviewer, Office of Pharmacovigilance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulatory Efforts to Promote Broader Use of Risk Management Plan in Clinical Practice