미국, 유럽, 일본의 레지스트리 구축 등 데이터기반 의료제품의 안전관리 동향

• 영문명: Current status and examples of patient registries in the US, Europe, and Japan and proposal of planning patient registry in Korea
• 발행기관: 대한약학회
• 저자명: 이정은(Jeong-Eun Lee) 심다영(Da-Young Shim) 윤동원(Dongwon Yoon) 노윤하(Yunha Noh) 신주영(Ju-Young Shin)
• 간행물 정보: 『약학회지』제64권 제5호(2020년), 358~368쪽, 전체 11쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2020.10.30

영문 초록

Over the past years regulatory agencies of Europe, the United States, and Japan have announced policies to facilitate the establishment and utility of registries at the national level in order to enhance post-marketing surveillance. With the recent increase in medical products safety issues, the Ministry of Food and Drug Safety (MFDS) is planning to build a patient registry system to monitor the safety of problematic products. The objective of this study is to examine the initiatives and the activities of health authorities in the US, Europe, and Japan and identify the essential features of well-operated registries. We collected information from official documents and postings on the health authority’s homepages about activities and efforts of the initiatives. We also surveyed and analyzed the official reports, the guide for each stakeholder of registries, and the information sheets for patients or doctors as case studies of well-designed registries. Therefore, this study suggests future directions on how to plan a long-term follow-up system and on how to design national level registries in Korea.

목차

서 론(Introduction)

연구 방법(Research Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

References

키워드

Registry patient registration patient safety long-term follow up