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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe

[S05] Clinical Trials Act: Experiences from the Past, the Way of the Future

Session Chair(s)

Kayoko  Kikuchi, PhD

Kayoko Kikuchi, PhD

  • Chief, Division of Management and Strategy
  • National Center For Child Health and Development, Japan
Clinical Trials Act has a big negative impact on clinical trials in Japan, and intervention trials had decreased drastically. The regulations for clinical trials differ depending on the study details: the study objectives and the source of funding, etc. As for a multinational clinical trial, we have to conduct in compliance with ICH-GCP, not only domestic rules in Japan. Principal investigators and research professionals are often confused and burdened by the variety and complexity of such rules. Clinical Trials Act gave us even more devastate situation. In this session, focusing on the law amendment, we will share the current issues and expectation for amendment of Clinical Trials Act from their perspective: government, industry and academia. Furthermore, we will discuss appropriate regulations in the future in order to achieve both ensuring the confidence and activating clinical trials.


Masahiko  Ozaki

Challenges and Responses With the Enforcement of Clinical Trials Act -From the Standpoint of Academia & Medical Institution -

Masahiko Ozaki

  • Manager, Ethical Review Support Section
  • National Cancer Center Hospital East, Japan
Hiroshi  Asai

Challenges and Responses with the Enforcement of Clinical Trials Act - From the Standpoint of Pharmaceutical Industry -

Hiroshi Asai

  • Associate Director, Medical Science Liaison, Medical Affairs, Japan
  • Astellas Pharma Inc., Japan
Jun  Yoshida

One and a Half Years after Implementation and Future Prospects

Jun Yoshida

  • Director, Office of Promotion of Clinical Trials
  • Ministry of Health, Labour and Welfare (MHLW), Japan