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[V7-S1] Draft Regulatory Guidance for Patient Registry and the Current Situation
Session Chair(s)
Akihiro Hirakawa, PHD
Professor, Department of Clinical Biostatistics, Institute of Science Tokyo, Japan
Under the Clinical Innovation Network (CIN) scheme, which aims for promoting medicine development by effective utilization of medical information generated by patient registries, an intensive development of patient registry has been preceded by an industry wide consortium of National Medical Research Centers (NCs) and Pharmaceutical companies, which was proposed by Ministry of Health, Labuor and Welfare. Under this circumstance, academic societies and PMDA have been dedicating to discuss data quality standard regarding the registry data which to be used for Japan NDA. There are various perspectives about data quality and way of registry operation. Is this session, we will discuss regulations surrounding the patient registry and issues for the ideal effective utilization of registry data.
Speaker(s)
Taro Shibata, MSC
Chief, Biostatistics Division, Center for Research Administration and Support, National Cancer Center, Japan
Discussion on “Draft: Basic Principles on the Reliability of Patients Registry Data When Utilized in the Application for Marketing Authorization and Post-Marketing Surveillance of Medical Products”
Harumasa Nakamura, MD, PHD
Director of Department of Clinical Research Support, , National Center of Neurology and Psychiatry, Japan
Current Status and Issues of Remudy in an Effort to Promote Clinical Innovation Network
Kazuhito Shiosakai
Manager, Statistical Analysis Group, Biostatistics & Data Management Department, Daiichi Sankyo Company, Limited, Japan
Expectation for the Disease Registry Data from a Pharmaceutical Company
Shimon Tashiro, PHD
Head, Office for Bioethics, Center for Public Health Science, National Cancer Center , Japan