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KIDS-APECPharmacovigilance CoE Training

Agenda

Home Program Agenda

Watch previous sessions
DAY 1 Wednesday, September 8th,
14:00 ~ 14:05
Opening remarks
Soo Youn Chung
(KIDS)
14:05 ~ 14:10
Introduction
Moonjung Kim
(KIDS)
14:10 ~ 14:50
Overview of the PV system in Korea Introduce the post-marketing pharmacovigilance (PV) and drug safety management in Korea
15:00 ~ 16:00
Current trends in PV PV automation from UMC perspective
  • Describe the remaining challenges and future implications for PV automation
  • Introduce cases of using AI in PV
  • How to validate results from AI
16:10 ~ 17:00
Risk management and risk minimization strategies - Opioid medications
  • Introduce the FDA’s current efforts in safety/risk management for opioid medications
  • How to evaluate the effectiveness of REMS for opioid medications
17:10 ~ 18:00
MedDRA as ICH terminology standard for coding safety information (Live) Learn about MedDRA’s scope, structure, and characteristics.
And understand the general MedDRA term selection principles with practical exercises
DAY 2 Thursday, September 9th,
14:00 ~ 14:50
Signal management - Regulatory perspective Learn about the overall process of signal management, and the major activities in each step of the process from a regulatory perspective
15:00 ~ 15:50
Signal management - Industry perspective Learn about the overall process of signal management, and the major activities in each step of the process from an industry perspective
16:00 ~ 16:50
Causality assessment (vaccines) - Lecture (Live hands-on exercise) Learn about the methods and considerations in vaccines causality assessments
17:00 ~ 17:50
Causality assessment (vaccines) - Presentation and discussion (Live hands-on exercise) Apply the lessons from the previous lecture through hands-on exercises
DAY 3 Friday, September 10th,
14:00 ~ 15:00
Safety and risk management for vaccines
  • Introduce the life cycle of vaccine safety and risk management
  • Learn about the recent advances in vaccine safety management and strategies for rapid decision-making (e.g., international collaborations, new data sources, etc.) from COVID-19 experience
15:10 ~ 15:50
PV inspections – Regulatory perspective
  • Learn about Good Pharmacovigilance Practices (GVP) Module III (PV inspections)
  • Share and analyze the most common or critical deficiencies found during inspections
  • Introduce novel approaches to inspections (e.g., remote methodologies)
16:00 ~ 16:50
Benefit-Risk assessment - Lecture (Live hands-on exercise) Learn about the methods and considerations in B-R assessments
17:00 ~ 17:50
Benefit-Risk assessment - Presentation and discussion (Live hands-on exercise) Apply the lessons from the previous lecture through hands-on exercises

2020 KIDS-APEC PV CoE Training