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| 제목 |
2018 KIDS-APEC Pharmacovigilance CoE Training |
| 작성자 |
조치관 |
등록일 |
2019-10-21 |
조회수 |
1339 |
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※ 원활한 환경을 위해 엣지 또는 크롬 브라우저에서 시청하시기 바랍니다. ※ If you don't see the videos, please use Google Chrome or Microsoft Edge. 01. Opening Remarks
02. Pharmacovigilance system in Korea
03. Overview of pharmacovigilance
04. Overview of pharmacovigilance Q&A
05. ICH E2B Guideline
06. ICH E2B Guideline Q&A
07. Sharing of various economies’ national adverse event reporting system (Korea)
08. Sharing of various economies’ national adverse event reporting system (USA)
09. Sharing of various economies’ national adverse event reporting system (Bayer)
10. AE reports review method - Case series review
11. AE reports review method - Case series review Q&A
12. AE reports review method - Pharmacovigilance and pharmacoepidemiology
13. AE reports review method - Pharmacovigilance and pharmacoepidemiology Q&A
14. Risk management plan - The regulatory point of view
15. Risk management plan - The regulatory point of view Q&A
16. Benefit-risk assessment
17. Benefit-risk assessment Q&A
18. Sharing of various economies’ risk communication system (Japan)
19. Sharing of various economies’ risk communication system (Singapore)
20. Sharing of various economies’ risk communication system Q&A
21. Introductory guide for MedDRA
22. Introductory guide for MedDRA Q&A
23. Closing Remarks
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