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1. Opening Remarks
2. Overview of the PV system in Korea
※ This lecture is conducted in Korean. Please enable subtitles in the YouTube video settings to view.
(Tap CC > settings⚙ > Subtitles/CC > Auto-translate > select your language)
3. Artificial Intelligence in PV – Value Proposition and critical appraisal
4. Potential Role and Unique Design/methods Considerations of Real-World Study of Biosimilars–Regulatory Perspective
5. A Global Perspective on Adverse Event Report Management, Sharing and Future Directions
6. EU PV inspections – Regulatory Perspectives
7. (Group Exercise) PV Inspections – Regulatory Perspectives
8. Pharmacovigilance and Signal Detection
9. Strategies for Benefit-Risk Analysis in Regulatory Perspective
10. The Role of Pharmacoepidemiology in Post-market Drug Safety Evaluations
11. Use of Real World Data for Regulatory Decision making in Korea
※ This lecture is conducted in Korean. Please enable subtitles in the YouTube video settings to view.
(Tap CC > settings⚙ > Subtitles/CC > Auto-translate > select your language)