850+
ATTENDEES25+
ECONOMIES40+
ORGANIZATION40+
SPEAKERSPROGRAM
DAY 1
Thu, September 05, 2024
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14:00 ~ 14:10
Opening remarks
Jeong Wyan Oh (KIDS)
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14:10 ~ 14:20
Introduction
E Na Song (KIDS)
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14:10 ~ 14:30
Overview of the PV system in Korea
Hyun-Joo Jung (KIDS)
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14:30 ~ 15:00
Artificial Intelligence in PV – Value Proposition and critical appraisal
Eva-Lisa Meldau (UMC)
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15:00 ~ 15:30
Potential Role and Unique Design/methods Considerations of Real-World Study of Biosimilars–Regulatory Perspective
Natasha Chihying Pratt (US FDA)
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16:00 ~ 16:30
A Global Perspective on Adverse Event Report Management, Sharing and Future Directions
Nils Peder Tomas Bergvall (UMC)
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16:30 ~ 17:00
EU PV inspections – Regulatory Perspectives
Susy Yeshika Olave Quispe (AEMPS)
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17:00 ~ 17:30
(Group Exercise) PV Inspections – Regulatory Perspectives
Susy Yeshika Olave Quispe (AEMPS)
DAY 2
Fri, September 06, 2024
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14:00 ~ 14:30
Pharmacovigilance and Signal Detection
Daniele Sartori (UMC)
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14:30 ~ 15:00
Strategies for Benefit-Risk Analysis in Regulatory Perspective
Jean-Christophe Delumeau (IPV)
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15:00 ~ 15:40
The Role of Pharmacoepidemiology in Post-market Drug Safety Evaluations
Gerald Joseph Dal Pan (US FDA)
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16:00 ~ 16:30
Use of Real World Data for Regulatory Decision making in Korea
Bonggi Kim (KIDS)
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16:30 ~ 17:00
Completing the Risk Management Cycle with Risk minimization interventions
Priya Bahri (EMA)
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17:00 ~ 17:30
Risk Communication: Core concepts and Multilayered Research Approaches
Priya Bahri (EMA)
NOTICE
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74
FAQ
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There is no any entry fee.
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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.
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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.