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2012 Workshops > Pharmacovigilance

DAY -1 (APR 2)

DAY -1 (APR 2) : DAY-1 (APR 2): Time, Session, Topic, Speaker
October 25, 2012
Time Session Topic Speaker
08:00-09:00 Registration
Opening Session
Moderator : Jin Ho Lee (Korean Society of Pharmacoepidemiology and Risk Management, KoPERM)
09:00-09:20 Opening Ceremony Opening Remarks
Welcoming Remarks Hee-sung Lee
(KFDA Commissioner)
Congratulatory Remarks Kyung Hwa Ko
(KHIDI President)
09:20-09:40 Keynote Speech Impact of Pharmacovigilance on Public Health Giwon Cho
(General Director,
Pharmaceutical Safety
Bureau, KFDA)Giwon Cho:PDF file download
09:40-09:50 Photo Session
09:50-10:00 Coffee & Tea Break
Session 1 : Current Status of Pharmacovigilance
Moderator : Chein Soo Hong (Yonsei University / Association of Regional Pharmacovigilance Centers))
10:00-10:30 Global Status of Pharmacovigilance (focusing on ICH status) (*Video Conference) Gerald Dal Pan
(US FDA)Gerald Dal Pan:PDF file download
10:30-11:00 Global Status of Pharmacovigilance (focusing on EU status)
- New European Pharmacovigilance Legislation
So Hyun Kim
(Bayer Korea)So Hyun Kim:PDF file download
11:00-11:30 The Need for Promoting Regulatory Convergence for Pharmacovigilance Activities
among APEC Economies
Nam-Kyong Choi
(Seoul Nat'lUniversity)Nam-Kyong Choi:PDF file download
11:30-12:00 Pharmacovigilance Regulation in Korea Joung Weon Oh
(KFDA)Joung Weon Oh:PDF file download
12:20-13:30 Lunch
Session 2: Regulatory System in Pharmacovigilance in the APEC Economies
Moderator : Byung Joo Park (Korea Institute of Drug Safety & Risk Management, KIDS)
13:30-14:00 Regulatory System in APEC Economy - China Ren Jingtian
(SFDA, China)Ren Jingtian:PDF file download
14:00-14:30 Regulatory System in APEC Economy - Singapore Adena Lim
(HSA, Singapore)Adena Lim:PDF file download
14:30-15:00 Regulatory System in APEC Economy - U.S.A. (*Video Conference) Gerald Dal Pan
(US FDA)Gerald Dal Pan:PDF file download
15:00-15:20 Coffee & Tea Break
Session 3: Issue and Challenges of Regulatory Harmonization in Pharmacovigilance
Moderators : Don Woong Choi (KFDA) & Yoon Jung Choi (BDM Consulting)
15:20-15:50 Role of the KIDS and Strategy for Activating the Pharmacovigilance System in Korea Byung Joo Park
(KIDS)Byung Joo Park:PDF file download
15:50-16:20 The Pharmacovigilance Activities for Risk Analysis and Challenges Ji Hye Ha
(KFDA)Ji Hye Ha:PDF file download
16:20-16:50 Challenges of International Harmonization on Pharmacovigilance Regulations - from Industry Perspective Si Nae Lee
(BMS Korea)Si Nae Lee:PDF file download
16:50-17:20 Issues and Challenges of Regulatory Harmonization in Pharmacovigilance - Academic Viewpoint Jin Ho Lee
(KoPERM)Jin Ho Lee:PDF file download
17:20-18:00 Panel Discussion
18:00-18:10 Closing Remarks Kui Lea Park (AHC)

DAY -2

DAY -2(October 26, 2012) : DAY-2(October 26, 2012)Time, Session, Topic, Speaker
October 26, 2012
10:30-15:30 Korea’s Pharmacovigilance Management System : Korea Institute of Drug Safety & Risk Management
Korea’s Pharmacovigilance Management System : Seoul National University Hospital