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2017
Watch previous sessions
DAY 1 Wednesday, September 13th, 2017
09:20 ~ 09:30
Opening remarks Watch a video
Bon-Ki Koo
(KIDS)
09:30 ~ 10:10
UMC tools
- VigiFlow, VigiBase, VigiLyze, VigiRank, VigiMatch, etc.
Watch a video

Q & A Watch a video
Magnus Wallberg
(UMC)
10:20 ~ 11:00
Advanced data collection methods
- Social media, Active surveillance, Mobile technologies, etc.
Watch a video

Q & A Watch a video
Gerald Dal Pan
(FDA)
11:10 ~ 12:10
Sharing of various economies’ national
pharmacovigilance (PV) system

USA Watch a video

Chinese Taipei Watch a video

Indonesia Watch a video

Korea Watch a video

Gerald Dal Pan
(FDA)
Lih-Jia Huang
(Taiwan FDA)
Siti Asfijah Abdoellah
(NADFC)
Yeonju Woo
(KIDS)
13:40 ~ 14:40
Qualitative and quantitative (data mining) evaluation
of safety signals
Watch a video

Q & A Watch a video
Sareeya Wechwithan
(Thai FDA)
15:00 ~ 17:20
[Individual Presentation] Detailed signal management
process of each country
- Signal detection, analysis, assessment and safety
measures within regional PV system

Chile Watch a video

Chinese Taipei Watch a video

Hong Kong Watch a video

Indonesia Watch a video

Korea Watch a video

Malaysia Watch a video

Mexico Watch a video

Papua New Guinea Watch a video

Peru Watch a video

Philippines Watch a video

Thailand Watch a video

Q & A Watch a video
All Participants
DAY 2 Thursday, September 14th, 2017
09:30 ~ 10:30
ICSR review methods
- The Regulatory Point of View
- Causality assessment of ICSRs
Watch a video

Q & A Watch a video
Jean Christophe Delumeau
(Bayer Pharma)
10:40 ~ 12:00
[Hands-on Exercise]
Causality assessment of ICSRs (Group discussion)
Ruth Savage
(UMC and NZPhvC, Speaker)
Jan Petracek
(PrimeVigilance and PharmInvent, Facilitator)
Sareeya Wechwithan
(Thai FDA, Facilitator)
Siti Asfijah Abdoellah
(NADFC, Facilitator)
13:30 ~ 14:30
Risk management plan (RMP) & Risk evaluation and
mitigation strategy (REMS) management Watch a video
Jean-Christophe Delumeau
(Bayer)
14:40 ~ 15:40
Risk communication and how to evaluate its effectiveness
Watch a video

Jan Petracek
(PrimeVigilance and PharmInvent)
16:00 ~ 17:00
Decision making cases/methods/evaluation Watch a video

Q & A Watch a video
Jan Petracek
(PrimeVigilance and PharmInvent)
2017

1. Opening remarks

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2. UMC tools

3. UMC tools Q&A

4. Advanced data collection methods

5. Advanced data collection methods Q&A

6. Sharing of various economies’ national PV system (USA)

7. Sharing of various economies’ national PV system (Chinese Taipei)

8. Sharing of various economies’ national PV system (Indonesia)

9. Sharing of various economies’ national PV system (Korea)

10. Qualitative and quantitative (data mining) evaluation of safety signal

11. Qualitative and quantitative (data mining) evaluation of safety signals Q&A

12. [Individual Presentation] Detailed signal management process of each country (Chile)

13. [Individual Presentation] Detailed signal management process of each country (Chinese Taipei)

14. [Individual Presentation] Detailed signal management process of each country (Hong Kong)

15. [Individual Presentation] Detailed signal management process of each country (Indonesia)

16. [Individual Presentation] Detailed signal management process of each country (Korea)

17. [Individual Presentation] Detailed signal management process of each country (Malaysia)

18. [Individual Presentation] Detailed signal management process of each country (Mexico)

19. [Individual Presentation] Detailed signal management process of each country (Papua New Guinea)

20. [Individual Presentation] Detailed signal management process of each country (Peru)

21. [Individual Presentation] Detailed signal management process of each country (Philippines)

22. [Individual Presentation] Detailed signal management process of each country (Thailand)

23. [Individual Presentation] Detailed signal management process of each country Q&A

24. ICSR review methods

25. ICSR review methods Q&A

26. Risk management plan (RMP) & Risk evaluation mitigation strategy (REMS) management

27. Risk communication and how to evaluate its effectiveness

28. Decision making cases methods evaluation

29. Decision making cases methods evaluation Q&A

2020 KIDS-APEC PV CoE Training