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| 제목 | 2020 KIDS-APEC Pharmacovigilance CoE Training | |||||
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| 작성자 | 조치관 | 등록일 | 2020-10-30 | 조회수 | 2287 | |
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1. Opening remarks 2. Overview of the pharmacovigilance system in Korea 3. Understanding ICH guidelines 4. Current trends in pharmacovigilance: A data science perspective from UMC 5. Safety and risk management for biologics 6. Evidence-based decision-making in pharmacoepidemiology: Using real-world data/real-world evidence (RWD/RWE) 7. Effective analysis of EMR data: The MOA project - Common Data Model (CDM) in Korea 8. Utilizing various data sources for signal detection and confirmation 9. Types of safety measures: Recall, revocation of permission, etc. 10. Risk management planning and risk minimization measures - Regulatory perspective 11. Risk management planning and risk minimization measures - Industry perspective |
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