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2016 AHC Pharmacovigilance Workshop Program

September 5, 2016 Novotel Ambassador Hotel Seoul, Republic of Korea
Champagne Hall (2F)

 

2016 AHC Pharmacovigilance Workshop Program : Time, Topics, Speakers
Time Topics Speakers
Monday, September 5, 2016
08:30 - 09:00 Registration
Opening Ceremony
09:00 - 09:15 Opening Remarks and Welcoming Remarks Yeowon Sohn (AHC)
Words of Encouragement/ Congratulatory Remarks Kyeong-Ho Lee (KPMA)
09:15 - 09:30 Keynote Speech Director General of
Pharmaceutical Safety
Bureau of MFDS
09:30 - 09:40 Group Photo
09:40 - 10:00 Break
Session I: Pharmacovigilance Activities
Chair: Su-Jung Lee (MFDS)
10:00 - 10:30 Pharmacovigilance Activities of EU (Regulatory perspective)
    - Efforts to improve the quality of AE reports
    - Current status of B-R assessment and        its challenges
Linda Harmark
(Netherlands Lareb)
10:30 - 10:40 Q&A and Discussion
10:40-11:10 Pharmacovigilance Activities of Asia-Pacific
    - Efforts to improve the quality of AE reports
    - Current status of B-R assessment and        its challenges
Cesar Luis Avalos Capristan (Peru DIGEMID)
Lanette Lee A. Querubin (Philippines FDA)
11:10-11:20 Q&A and Discussion
11:20-11:30 Break
11:30-12:00 Pharmacovigilance Activities of Industry
    - Efforts to improve the quality of AE reports
    - Current status of B-R assessment and        its challenges
Yong-soo Kim
(Novartis Korea)
Kazuhiko Ishida (JPMA)
12:00-12:10 Q&A and Discussion
12:10-13:30 Luncheon
Session II: Adverse Event (AE) Reporting and Collecting
Chair: Gerald Dal Pan (U.S. FDA)
13:30-14:00 Effective methods for collecting high quality and reliable reports Anki Hagstrom (WHO-UMC)
14:00-15:00 Panel Discussion Linda Harmark (Netherlands Lareb)
Anki Hagstrom (WHO-UMC)
Lanette Lee A. Querubin (Philippines FDA)
Nafiza Mohd Ismail
(Malaysia NPRA)
Siti Asfijah Abdoellah (Indonesia NADFC)
Yaowares Oppamayun
(Thai FDA)
Yong-Soo Kim
(Novartis Korea)
15:00-15:20 Break
Session III: Adverse Event (AE) Evaluation
Chair: Linda Harmark (Lareb)
15:20-15:50 Effective methods for Risk-Benefit evaluation Gerald Dal Pan (U.S. FDA)
15:50-16:50 Panel Discussion Gerald Dal Pan (U.S. FDA)
Daisuke Tanaka (WHO)
Kazuhiko Ishida (JPMA)
Yong-Soo Kim
(Novartis Korea)
Cesar Luis Avalos Capristan (Peru DIGEMID)
Wrap up
16:50-17:05 Wrap up and Conclusion Director General of
Pharmaceutical Safety
Bureau of MFDS
17:05-17:15 Closing Remarks Yeowon Sohn (AHC)