1.Establishment of Drug Risk Management System -the Promise of Safety Science Approaching from Non-Clinical Safety
Ichiro TSUNENARI ; Kyoko BARATA ; Naoki NAKAYAMA ; Shoichiro SUGAI ; Motomu TAN ; Shoji SASAKI ; Takashi UNNO ; Kazuhiko MATSUMOTO
Japanese Journal of Pharmacoepidemiology 2008;13(1):29-38
A questionnaire survey of risk management systems for medical products was conducted with the cooperation of domestic and foreign pharmaceutical companies. As for the foreign companies, it was revealed that specialized safety management teams and data-management committees are established to formulate risk management plans in order to create systems that assure consistent risk management for each company. In addition, it was revealed that toxicologists are incorporated in the central decision making organization. As for domestic companies, it turned out that no less than half of the respondents pay attention to consistent risk management from the development stage through the post marketing stage. From now on, it will be essential to consolidate safety data, improve the accessibility of centralized safety data from the relevant departments, and establish systems to provide consistent risk management from the development stage to the post marketing stage.
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