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- 저자 : 채규한 ( Gyuhan Chae ) (검색결과 1 건)
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서정원 ( Jeong-won Seo ),이재옥 ( Jaeok Lee ),채규한 ( Gyuhan Chae ),도원임 ( Won-im Do ),이상훈 ( Sang-hun Lee ),정래석 ( Raeseok Jung ),신원 ( Won Shin ) 한국보건정보통계학회(구 한국보건통계학회) 2017 보건정보통계학회지 Vol.42 No.3
The aim of this study is to provide a method to apply the electronic data standard for electronic transmission of individual case safety reports (ICSRs) in Korea. In Korea, it is necessary to implement the ICH E2B guideline and the ICH MedDRA guideline within 5 years after approval to join ICH members in November 2016. With the spread of the internet network and the IT infrastructure worldwide, Data standardization has been developed not only by major countries such as the US, Europe, and Japan, but also by around the world. In addition, it is necessary to strengthen voluntary or mandatory reporting from consumers, pharmaceutical companies, and healthcare professionals by following the standardized electronic information exchange sys tem for international sharing. This can be an opportunity to overcome limitations on the quality and quantity of information available at the time of authorization. Based on the data system applying the electronic standards, it is possible to search and prevent Korean inherent side effects by using the collected and analyzed information. The exchange of information of standardized data will enable regulatory authorities to communicate with data from different structure as well as many other countries with a single common document. We first reviewed the necessity of development of data standard for drug safety reporting. The ICH E2B guideline adopted as an international standard has been analyzed and the need for introduction into Korea has been examined. In major ICH regions like US, EU and Japan, regional implementation guides for E2B (R3) guideline were prepared and implemented in accor dance with the guide. The guides and the status of these countries were compared and analyzed. Regional implementation guide for introducing ICH E2B, an international standard, in Korea was made which was reflecting domestic regulations such as pharmaceutical safety management regulations.
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