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KIDS-APECPharmacovigilance CoE Training

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2020
Watch previous sessions
DAY 1 Wednesday, September 16th, 2020
14:00 ~ 14:05
Opening remarks Watch a video
Soon Young Han
(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.
Watch a video
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.
  • 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
Watch a video
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.
  • Social media, a reservoir of safety information
  • Artificial intelligence (AI) in pharmacovigilance, etc
Watch a video
Lucie Gattepaille
(WHO-UMC)
16:50 ~ 17:40
Safety and risk management for biologics
  • Learn about pharmacovigilance considerations for biologics.
  • Understand long-term follow-up observations for safety management of advanced therapy medicinal products.
Watch a video
Steven Anderson
(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)
  • 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.
Watch a video
Gerald Dal Pan
(FDA)
15:00 ~ 15:40
Effective analysis of EMR data : The MOA project – Common Data Model (CDM) in Korea
  • Introduce the CDM in Korea.
  • Share the process and considerations for the CDM development.
Watch a video
Bonggi Kim
(KIDS)
16:00 ~ 16:20
Utilizing various data sources for signal detection and confirmation
  • Introduce various data sources for signal detection.
  • Learn the integrated utilization of spontaneous reports database and other sources in signal assessment.
Watch a video
Rebecca Chandler
(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.
Watch a video
In Sun Lee
(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).
Watch a video
Jan Petracek
(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.
Watch a video
Jan Petracek
(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.
Jan Petracek
(ISoP)
17:20 ~ 17:50
[Hands-on Exercise] (2) Presentation :
Implementing risk minimization measures in healthcare
Share the discussions from the case studies.
Jan Petracek
(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

2020 KIDS-APEC PV CoE Training