1. Opening remarks

2. Pharmacovigilance system in Korea

3. Overview of pharmacovigilance

4. Overview of pharmacovigilance Q&A

5. ICH E2B Guideline

6. ICH E2B Guideline Q&A

7. Sharing of various economies’ national adverse event reporting system (Korea)

8. Sharing of various economies’ national adverse event reporting system (USA)

9. 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