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KIDS-APECPharmacovigilance CoE Training

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2019
Watch previous sessions
DAY 1 Wednesday, September 4th, 2019
09:00 ~ 09:10
Opening remarks Watch a video
Soon Young Han
(KIDS)
09:10 ~ 09:50
Overview of Pharmacovigilance system in Korea Watch a video
Q & A Watch a video
Moonjung Kim
(KIDS)
09:50 ~ 10:20
Sharing action plans for the regulatory harmonization in pharmacovigilance
Watch a video

Q & A Watch a video
Yubin Lee
(MFDS)
10:40 ~ 12:10
Pharmacovigilance and Medication Error Reporting system Watch a video
Q & A Watch a video
Gerald Dal Pan
(FDA)
14:40 ~ 16:10
Sharing Various Economies’ Strategies to Improve Their Pharmacovigilance System

Chile Watch a video

Indonesia Watch a video

Philippines Watch a video

Taiwan Watch a video

Thailand Watch a video
Maria Rodriguez Galan
(Public Health Institute of Chile)
Rahmaniah
(Indonesia NADFC)
Julie Ann Capuchino
(FDA Philippines)
Kuo-Teng Hung
(Taiwan FDA)
Cholticha Sonsupap
(Thai FDA)
16:30 ~ 17:10
Effective Risk Communication – PMDA experience Watch a video
Q & A Watch a video
Izumi Oba
(PDMA)
DAY 2 Thursday, September 5th, 2019
09:00 ~ 09:50
Quality Management of Pharmacovigilance -Pharmacovigilance Inspection
Watch a video

Q & A Watch a video
Gerald Dal Pan
(FDA)
10:00 ~ 11:00
Principles of adverse event assessment: Signal detection
Watch a video

Q & A Watch a video
Ruth Savage
(WHO-UMC)
11:10 ~ 12:10
Tools for enhanced Pharmacovigilance: Advanced signal detection
Watch a video

Q & A Watch a video
Magnus Ekelo
(WHO-UMC)
13:30 ~ 15:00
[Hands-on Exercise]
Adverse event assessment: Signal detection
Ruth Savage,
Magnus Ekelo

(WHO-UMC)
15:20 ~ 16:20
Risk management plan (RMP)
-Specific product-related RMPs, tools and activities Watch a video
Q & A Watch a video
Christine Ho
(HSA)
16:20 ~ 16:30
Wrap up and Closing Remarks Watch a video
Soo Youn Chung
(KIDS)
2019

1. Opening remarks

2. Overview of the pharmacovigilance system in Korea

3. Overview of pharmacovigilance system in Korea Q&A

4. Sharing action plans for the regulatory harmonization in pharmacovigilance

5. Sharing action plans for the regulatory harmonization in pharmacovigilance Q&A

6. Pharmacovigilance and medication error reporting system

7. Pharmacovigilance and medication error reporting system Q&A

8. Sharing various economies’ strategies to improve their pharmacovigilance system (Chile)

9. Sharing various economies’ strategies to improve their pharmacovigilance system (Indonesia)

10. Sharing various economies’ strategies to improve their pharmacovigilance system (Philippines)

11. Sharing various economies’ strategies to improve their pharmacovigilance system (Taiwan)

12. Sharing various economies’ strategies to improve their pharmacovigilance system (Thailand)

13. Effective risk communication - PMDA experience

14. Effective risk communication - PMDA experience Q&A

15. Quality management of pharmacovigilance - Pharmacovigilance inspection

16. Quality management of pharmacovigilance - Pharmacovigilance inspection Q&A

17. Principles of adverse event assessment - Signal detection

18. Principles of adverse event assessment - Q&A

19. Tools for enhanced pharmacovigilance_ advanced signal detection

20. Tools for enhanced pharmacovigilance_ advanced signal detection Q&A

21. Risk management plan (RMP) - Specific product-related RMP, tools and activities

22. Risk management plan (RMP) - Specific product-related RMP, tools and activities Q&A

23. Wrap up and Closing Remarks

2020 KIDS-APEC PV CoE Training