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[V7-S1] Draft Regulatory Guidance for Patient Registry and the Current Situation
Session Chair(s)
Akihiro Hirakawa, PhD
Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
Tokyo Medical and Dental University, 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)
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”
Taro Shibata, MSc
Center for Research Administration and Support, National Cancer Center, Japan
Chief, Biostatistics Division
Current Status and Issues of Remudy in an Effort to Promote Clinical Innovation Network
Harumasa Nakamura, MD, PhD
National Center of Neurology and Psychiatry, Japan
Director of Department of Clinical Research Support,
Expectation for the Disease Registry Data from a Pharmaceutical Company
Kazuhito Shiosakai
Daiichi Sankyo Company, Limited, Japan
Manager, Statistical Analysis Group, Biostatistics & Data Management Department
Shimon Tashiro, PhD
National Cancer Center , Japan
Head, Office for Bioethics, Center for Public Health Science