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[S05] Clinical Trials Act: Experiences from the Past, the Way of the Future
Session Chair(s)
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.
Speaker(s)
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
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
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