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KMID : 1022920150040010001
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Journal of Korean Academy of Social & Managed Care Pharmacy
2015 Volume.4 No. 1 p.1 ~ p.6
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The Quality Control of Post-Authorization Study of Re-Examination in Korea
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Park Eun-Ja
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Abstract
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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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KEYWORD
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Re-examination, post-authorization study, quality control
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