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2020
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DAY 1
Wednesday, September 16th, 2020
14:00 ~ 14:05
Opening remarks
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Soon Young Han
(KIDS)
(KIDS)
14:05 ~ 14:10
Introduction
Moonjung Kim(KIDS)
14:10 ~ 14:50
Overview of the pharmacovigilance system in Korea
Introduce the post-marketing pharmacovigilance and drug safety management in Korea.
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Sun Mi Shin(KIDS)
15:00 ~ 15:50
Understanding ICH guidelines
Learn ICH E2 guideline and understand the significance of international harmonization in safety Data management of medicinal products.
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- 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
Gerald Dal Pan(FDA)
16:00 ~ 16:40
Current trends in pharmacovigilance : A data science perspective from UMC
Explore the use of new technologies in pharmacovigilance.
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- Social media, a reservoir of safety information
- Artificial intelligence (AI) in pharmacovigilance, etc
Lucie Gattepaille
(WHO-UMC)
(WHO-UMC)
16:50 ~ 17:40
Safety and risk management for biologics
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- Learn about pharmacovigilance considerations for biologics.
- Understand long-term follow-up observations for safety management of advanced therapy medicinal products.
Steven Anderson
(FDA)
(FDA)
DAY 2
Thursday, September 17th, 2020
14:00 ~ 14:50
Evidence-based decision-making in pharmacoepidemiology : Using real-world data/real-world evidence (RWD/RWE)
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- 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.
Gerald Dal Pan
(FDA)
(FDA)
15:00 ~ 15:40
Effective analysis of EMR data : The MOA project – Common Data Model (CDM) in Korea
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- Introduce the CDM in Korea.
- Share the process and considerations for the CDM development.
Bonggi Kim
(KIDS)
(KIDS)
16:00 ~ 16:20
Utilizing various data sources for signal detection and confirmation
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- Introduce various data sources for signal detection.
- Learn the integrated utilization of spontaneous reports database and other sources in signal assessment.
Rebecca Chandler
(WHO-UMC)
(WHO-UMC)
16:30 ~ 17:10
Types of safety measures : Recall, revocation of permission, etc
Learn procedures and considerations for each type of safety measures and examine actual cases.
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In Sun Lee
(MFDS)
(MFDS)
DAY 3
Friday, September 18th, 2020
14:00 ~ 15:00
Risk management planning and risk minimization measures-Regulatory perspective
Review current regulatory requirements for risk minimization plans (RMPs).
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Jan Petracek
(ISoP)
(ISoP)
15:10 ~ 16:10
Risk management planning and risk minimization measures-Industry perspective
Learn about effective risk management reflecting different characteristics of medicinal products :
Designing, implementing, and evaluating RMPs.
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Designing, implementing, and evaluating RMPs.
Jan Petracek
(ISoP)
(ISoP)
16:20 ~ 17:10
[Hands-on Exercise] (1) Discussion :
Implementing risk minimization measures in healthcare Apply the introduced risk minimization measures on case studies.
Implementing risk minimization measures in healthcare Apply the introduced risk minimization measures on case studies.
Jan Petracek
(ISoP)
(ISoP)
17:20 ~ 17:50
[Hands-on Exercise] (2) Presentation :
Implementing risk minimization measures in healthcare Share the discussions from the case studies.
Implementing risk minimization measures in healthcare Share the discussions from the case studies.
Jan Petracek
(ISoP)
(ISoP)
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