재심사 대상 의약품의 시판 후 조사 질 관리에 대한 연구

• 영문명: The Quality Control of Post-Authorization Study of Re-Examination in Korea
• 발행기관: 한국보건사회약료경영학회
• 저자명: 박은자(Eunja Park)
• 간행물 정보: 『한국보건사회약료경영학회지』제4권 제1호, 1~13쪽, 전체 13쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2015.11.30

영문 초록

BACKGROUND Re-examination system was post-marketing safety measures for drugs in Korea. The objective of this study was to examine experts’ opinions for post-authorization study and current status of quality control of study in pharmaceutical company to improve the quality of post-authorization study of re-examination. METHODS We conducted mail survey for pharmaceutical company (2014. 9. 15-10. 17) and e-mail survey for experts (2014. 10. 1-10. 17). Questionnaires for 29 pharmaceutical companies and for 19 experts were collected and analyzed. RESULTS More than 80% of experts said that quality control of post-authorization study is needed to improve the study, however, many pharmaceutical companies had a difficulty in conducting study. Seventy two percent of companies pointed out low cooperation of survey sites as difficulty in monitoring of post-authorization study. CONCLUSION Quality control of post-authorization study of re-examination system needs to be improved to provide reliable evidence for drug safety.

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연구방법

연구결과

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감사의 말씀

참고문헌

키워드

Re-examination post-authorization study quality control