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850+

ATTENDEES

25+

ECONOMIES

40+

ORGANIZATION

40+

SPEAKERS

PROGRAM

DAY 1 Thu, September 05, 2024
  • 14:00 ~ 14:10
    Opening remarks

    Jeong Wyan Oh (KIDS)

  • 14:10 ~ 14:20
    Introduction

    E Na Song (KIDS)

  • 14:10 ~ 14:30
    Overview of the PV system in Korea

    Hyun-Joo Jung (KIDS)

  • 14:30 ~ 15:00
    Artificial Intelligence in PV – Value Proposition and critical appraisal

    Eva-Lisa Meldau (UMC)

  • 15:00 ~ 15:30
    Potential Role and Unique Design/methods Considerations of Real-World Study of Biosimilars–Regulatory Perspective

    Natasha Chihying Pratt (US FDA)

  • 16:00 ~ 16:30
    A Global Perspective on Adverse Event Report Management, Sharing and Future Directions

    Nils Peder Tomas Bergvall (UMC)

  • 16:30 ~ 17:00
    EU PV inspections – Regulatory Perspectives

    Susy Yeshika Olave Quispe (AEMPS)

  • 17:00 ~ 17:30
    (Group Exercise) PV Inspections – Regulatory Perspectives

    Susy Yeshika Olave Quispe (AEMPS)

DAY 2 Fri, September 06, 2024
  • 14:00 ~ 14:30
    Pharmacovigilance and Signal Detection

    Daniele Sartori (UMC)

  • 14:30 ~ 15:00
    Strategies for Benefit-Risk Analysis in Regulatory Perspective

    Jean-Christophe Delumeau (IPV)

  • 15:00 ~ 15:40
    The Role of Pharmacoepidemiology in Post-market Drug Safety Evaluations

    Gerald Joseph Dal Pan (US FDA)

  • 16:00 ~ 16:30
    Use of Real World Data for Regulatory Decision making in Korea

    Bonggi Kim (KIDS)

  • 16:30 ~ 17:00
    Completing the Risk Management Cycle with Risk minimization interventions

    Priya Bahri (EMA)

  • 17:00 ~ 17:30
    Risk Communication: Core concepts and Multilayered Research Approaches

    Priya Bahri (EMA)

NOTICE


  • 74

FAQ

  • There is no any entry fee.

  • Please submit an online application form at the training website(kidscoe.drugsafe.or.kr).

     

    After submitting your registration form, a confirmation email will be sent at your registered email address.

  • Officials from Regulatory Authorities and Public Institutions(PV centers).

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
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