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14th DIA Japan Annual Meeting 2017


[Student Session] Clinical Trial Protocol Development

    Session Chair(s)
      Maori  Ayabe

      Maori Ayabe

      • Undergraduate Student, Faculty of Pharmaceutical Sciences
      • Chiba University, Japan
      Shouhei  Iimura

      Shouhei Iimura

      • Student
      • Keio University, Japan
      Aya  Okada

      Aya Okada

      • Undergraduate Student, School of Pharmacy
      • Nihon University, Japan
      Miho  Sato

      Miho Sato

      • Undergraduate Student, School of Pharmacy
      • Showa University, Japan
    Clinical trials are essential for evaluating drug safety and efficacy. Moreover, consideration of subjects and choices such as trial designs and evaluation methods are important in conducting them. Therefore, how are ethical and scientific clinical trials designed? This session will provide a lecture on the essence of developing a clinical trial protocol. Subsequently, you will conduct a protocol development by group work and improve understanding. Through active discussion, we would like you to experience the drafting process of a trial plan. In addition, it is desirable to read the following reference because we will deal with antidiabetic drugs as materials for group work: Ministry of Health, Labour and Welfare. “Guideline for Clinical Evaluation of Oral Hypoglycemic Agents”. https://www.pmda.go.jp/files/000208194.pdf, (accessed 2017-05-23).
    Speaker(s)
      Hideki  Mizusako

      Points to Consider for Developing Clinical Study Protocol - Based on the Experience and Actual Cases -

      Hideki Mizusako

      • Clinical Development Department
      • Daiichi Sankyo Co., Ltd., Japan
      Yuka  Sakagami

      Yuka Sakagami

      • Reviewer, Office of New Drug I
      • 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