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KIDS-APECPharmacovigilance CoE Training

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2021

1. Opening remarks

2. Overview of the PV system in Korea

3. Current trends in PV - PV automation from UMC perspective

4. Risk management and risk minimization strategies - Opioid medications

5. MedDRA as ICH terminology standard for coding safety information

6. Signal management - Regulatory perspective

7. Signal management - Industry perspective

8. [Hands-on exercise] Causality assessment (vaccines) - Lecture

9. Safety and risk management for vaccines

10. PV inspections - Regulatory perspective

11. [Hands-on exercise] Benefit-Risk assessment - Lecture

2020 KIDS-APEC PV CoE Training