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Tokyo Big Sight

Nov 10, 2019 9:30 AM - Nov 12, 2019 5:40 PM

3-11-1 Ariake, Koto-ku, Tokyo, 135-0063 Japan

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

Development Office for Translational Research

Fujita Health University, 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, MS

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

Masahiko Ozaki, MS

National Cancer Center Hospital East, Japan

Manager, Ethical Review Support Section

Hiroshi  Asai

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

Hiroshi Asai

Astellas Pharma Inc., Japan

Associate Director, Medical Science Liaison, Medical Affairs, Japan

Jun  Yoshida

One and a Half Years after Implementation and Future Prospects

Jun Yoshida

Ministry of Health, Labour and Welfare (MHLW), Japan

Director, Office of Promotion of Clinical Trials

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