Home Archives 2020
- E2B(R3) Clinical Safety Data Management : Data elements for transmission of individual case safety reports (ICSRs)
- E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)
- E2D : Post-approval Safety Data Management :
Definitions and standards for expedited reporting
- Social media, a reservoir of safety information
- Artificial intelligence (AI) in pharmacovigilance, etc
- Learn about pharmacovigilance considerations for biologics.
- Understand long-term follow-up observations for safety management of advanced therapy medicinal products.
- Explore current status on the use of RWD/RWE in drug safety management.
- Explore how to use RWD/RWE in regulatory decision-making.
- Understand regulatory considerations for designing RWD/RWE studies.
- Introduce the CDM in Korea.
- Share the process and considerations for the CDM development.
- Introduce various data sources for signal detection.
- Learn the integrated utilization of spontaneous reports database and other sources in signal assessment.
Designing, implementing, and evaluating RMPs.
Implementing risk minimization measures in healthcare Apply the introduced risk minimization measures on case studies.
Implementing risk minimization measures in healthcare Share the discussions from the case studies.
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