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14th DIA Japan Annual Meeting 2017


[V2-S5] For RMP That can be Utilized by Healthcare Professionals

    Session Chair(s)
      Kazuhiko  Ishida, MSc, RPh

      Kazuhiko Ishida, MSc, RPh

      • Associate 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

      Current Status of RMP Utilization in Hospitals and Recommendations for RMP - Based on AMED Research Narukawa Team Results

      Masahiro Hayashi, PhD

      • Director, Department of Pharmacy
      • Toranomon Hospital, Japan
      Taku  Obara, PhD

      RMP Utilization for ADR Reporting in the Community Health Care Setting

      Taku Obara, PhD

      • Associate Professor, Tohoku University Graduate School of Medicine,
      • Tohoku University Hospital, Japan
      Shinya  Takemoto, MSc

      Pharmaceutical Company’s Approach for the Usage of Risk Management Plan (RMP) in Medical Settings

      Shinya Takemoto, MSc

      • Group Leader, Drug Safety Coordination Dept., Drug Safety Div.
      • Chugai Pharmaceutical Co., Ltd., Japan
      Yusuke  Matsunaga, PhD

      Regulatory Efforts to Promote Broader Use of Risk Management Plan in Clinical Practice

      Yusuke Matsunaga, PhD

      • Reviewer, Office of Safety II
      • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Contact us

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-6214-0574
Fax: +81-3-3278-1313
Japan@DIAglobal.org
www.diajapan.org