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KIDS-APECPharmacovigilance CoE Training

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2024

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)

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