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ATTENDEES30+
ECONOMIES40+
ORGANIZATION50+
SPEAKERSPROGRAM
DAY 1
Tue, October 28, 2025
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13:30 ~ 13:40
Opening remark
Soojung Sohn (KIDS)
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13:40 ~ 14:50
Overview of the Pharmacovigilance System in Korea
Hyun-Joo Jung (KIDS)
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15:00 ~ 15:40
ICH E2B(R3) Guideline Updates and the Future of ICSR Reporting
Thomas Paternoster-Howe (EMA)
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15:40 ~ 16:30
Enhancing Pharmacovigilance and Reducing Medication Errors by Applying AI to Product Labels
Jean Christophe Delumeau (IPV)
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16:50 ~ 17:20
Implementation of Artificial Intelligence in Pharmacovigilance
Gerald Dal Pan (US FDA)
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17:20 ~ 17:50
Regulatory Pharmacoepidemiology & Data-Driven Drug-Safety Research
Gerald Dal Pan (US FDA)
DAY 2
Wed, October 29, 2025
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13:30 ~ 14:10
Evolving Post-Marketing Safety Management: Opportunities and Challenges in Integrating RMP
Jamie Wilkins (Pfizer)
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14:10 ~ 14:50
The Globalization of risk management
Jan Petracek (iVigee)
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15:20 ~ 15:50
Harnessing Real-World Evidence for Pharmacovigilance
Claus Møldrup (DMA)
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15:50 ~ 16:20
Pharmacovigilance: Signal Detection Beyond Traditional Disproportionality Analysis
Henric Taavola-Gustafsson (WHO-UMC)
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16:50 ~ 18:00
Structured Benefit-Risk Assessment (BRA) and Preference-based BRA
Shahrul Mt-Isa (MSD)
NOTICE
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We have compiled the answers from our speakers to questions submitted in advance or posted in the chat that could not be addressed during the live sessions.
Please check the attached PDF for the full Q&A list.
👇👇 DOWNLOAD 👇👇
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We are now accepting pre-submitted questions for the upcoming 2025 KIDS-APEC Pharmacovigilance (PV) Training (October 28–29, 2025).
Selected questions may be addressed during the LIVE Q&A session.
👉 [Submit Your Questions Here]
Your active participation is highly appreciated!
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Thank you for your participation in the 2025 KIDS-APEC PV Training.
The training materials are now available.
Please download the files from the attached documents below.
The password for opening the files has been sent to your registered email address.
※ The materials are provided for educational use only and must not be shared or reproduced without permission.
※ DAY 2 materials will be uploaded later once all files have been collected.
📅 Availability Period: Oct 20 (Mon) – Oct 29 (Wed), 2025
📩 Inquiries: kidscoe@drugsafe.or.kr
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📢 Please check out the “Guidelines for Participants” for the 2025 KIDS-APEC PV Training!
For detailed instructions on participation, interpretation, Q&A, and certificates,
please download the attached document below.
👇👇 DOWNLOAD 👇👇
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FAQ
Need help?
‘KIDS-APEC Pharmacovigilance CoE Training’ will be held online.If you have any questions, please contact us by e-mail.