컨텐츠바로가기
Insert title here

20242024 KIDS-APEC PV Training

REGISTRATION LIVE

KIDS-APEC
PV CoE Clip

KIDS is very pleased to invite you to our KIDS-APEC Pharmacovigilance CoE training.

DAY 1 Thu, September 05, 2024
14:00 ~ 14:05
Opening remarks

 

14:05 ~ 14:10
Introduction

 


14:00 ~ 14:05
Opening remark

<p>&nbsp;</p>


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
Introducing pharmacovigilance system for innovative biotherapeutics

To understand the evolving international, regional, and country-specific safety regulatory frameworks applicable to biotherapeutics, addressing the specificities and challenges inherent to most innovative therapies. 

16:10 ~ 17:00
Pharmacovigilance of COVID-19 vaccines in United States

  • Overview of pharmacovigilance methods for COVID-19 vaccines/treatments
  • Updates on safety data on COVID-19 vaccines/treatments
  • Share long term follow-up plans and strategies for COVID-19 vaccines/treatments
  • Share lessons learned

17:10 ~ 18:00
Ways to encourage AE reporting

  • Overview
  • How to directly collect ICSR from apps on portable devices
  • Share lessons learned

DAY 2 Fri, September 06, 2024
14:00 ~ 14:50
Recent advances in medication error detection

Overview of both pre-market and post-market activities to detect and minimize medication errors 

15:00 ~ 15:50
Recent trends in data mining

 

  • Overview of traditional data-mining approach: PRR, ROR, IC
  • Updates on data mining methods
  • 1) AI and machine learning approach
  • 2) other novel approach
  • Examples of data-mining in immunotherapy and Redemsivir cases, et al
  • Lessons learned and future prospects

 

16:00 ~ 16:50
Utilizing routinely collected health data for signal validation and prioritization

  • Introduce routinely collected health data as information source for signal management
  • Understand the routine signal management process and its challenges
  • Learn about the integrated utilization of case report and routinely collected health data in signal validation and prioritization

17:00 ~ 17:50
Risk management planning and risk minimization measures of cell and gene therapy products

  • Developing risk-management plans for cell and gene therapy products
  • Learn about the use of registries

→ Process for designing, planning, and implementing registries
→ Data quality considerations 

  • Consideration for long-term follow-up studies

→ Planning long-term follow-up studies
→ Case sharing 

Need help?

‘KIDS-APEC Pharmacovigilance CoE Training’ will be held online.
If you have any questions, please contact us by e-mail.
Send E-mail
Insert title here