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RISS 인기검색어
- 검색키워드
- 저자 : 박한희(Han-Heui Park) (검색결과 3 건)
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미국, 유럽, 일본의 실사용데이터 연구사업 추진현황과 시사점
박한희(Han-Heui Park),정규원(Gyu-Won Jung),성희진(Higin Sung),신주영(Ju-Young Shin) 대한약학회 2020 약학회지 Vol.64 No.1
With the growing interest in big data, regulatory agencies in United States, Europe, and Japan are showing active movements to use real world data (RWD) and real world evidence (RWE). Following the global movements, it is necessary to establish the foundation for utilizing RWD in drug safety management in Korea. The purpose of this study is to examine and analyze the current status of research projects related to RWD in US, Europe, and Japan. We investigated the current state of global research projects on the use of RWD and RWE by utilizing many of the informative resources as follow. We collected information posted on websites operated by each country’s regulatory authority. Also we referred to publications and guidance around the enhanced use of RWE for health-care decision-makers. In addition, web seminars introducing ongoing research projects allowed us to gain substantial amount of resources. We classified research projects into 4 areas; data integrity (accuracy and consistency of data), post-market drug safety monitoring, indication expansion, and consulting and education fields. In this way, we could consider each country’s different market environment and institutional bases. Therefore, this study suggests future directions to prepare research projects for the introduction of Korea’s RWD.
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실사용데이터/실사용근거를 활용한 FDA와 EMA의 규제적 의사결정 사례 분석
성희진(Hi Gin Sung),박한희(Han-Heui Park),정규원(Gyu-Won Jung),신주영(Ju-Young Shin) 대한약학회 2020 약학회지 Vol.64 No.2
Lately, the use of Real-World Data (RWD)/Real-World Evidence (RWE) have been actively expanded in regulatory decisions. We aimed to investigate how RWD/RWE were used in pursuit of supporting regulatory actions of FDA and EMA. We selected 9 examples of regulatory decision making with the support of RWD/RWE. To identify information included in RWE submission, we referred to the official website of US FDA or EMA. In addition, we used ClinicalTrials.gov and Medline database to collect information on study design using RWE and RWD source used to generate RWE. Our study drugs were classified into 3 parts according to regulatory context; primary approval, label expansion, and regulatory response to safety signal after marketing. Among these examples, 5 biologic products including 1 vaccine had gone through accelerated review supported by RWE. To summarize, we investigated several examples where RWD/RWE has already been used in the process of making regulatory decisions for assessing the safety of drugs as well as their effectiveness. We recommend further discussions on advancing the use of RWD/RWE in regulatory context to improve patient access to novel rare disease treatments and provide more efficient safety assessment.
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한국, 일본, 대만에서의 의약품 부작용 피해구제 제도 현황 조사
안상완(Sang-Wan An),노윤하(Yunha Noh),백연희(Yeon-Hee Baek),박한희(Han-Heui Park),박소희(So-Hee Park),박성민(Sungmin Park),신주영(Ju-Young Shin) 대한약학회 2019 약학회지 Vol.63 No.4
Abstract The adverse drug reaction relief system is no-fault compensation system which provides compensation for severe injuries that were caused by adverse reaction even after proper use of medicines. The purpose of this study is to evaluate current status of the adverse drug reaction relief system in Japan, Taiwan, and Korea. We investigated the relief system in above three countries through websites, literatures, reports, spot investigation and e-mail questionnaires. Although great similarities for the relief system were recognized among the three countries, the difference among the countries and the unique characteristics of each country’s relief system was also identified; for example, the relief for injuries by offlabel uses, details of relief benefits, the relief payment for the adverse drug reactions, and the compensation for medical expenses which is classified as non-reimbursement treatment. Therefore, it is possible to establish more valuable no-fault compensation system in Korea through application of advantage and experience for the relief system in Japan and Taiwan.
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