Overview

ICH was established in 1990 and has since facilitated professionals from the three global regions (EU Japan and USA) to formulate appropriate practice guidelines. The rationale behind its formation was the growing understanding within scientific communities that the goals of pharmacovigilance services would be better met if there existed a greater degree of uniformity regarding testing and safety regulations across the different regions.

As an essential part of patient safety, pharmacovigilance is of worldwide interest and should expand its scope and focus on new emerging issues. The change in pharmacovigilance paradigm is a global trend and Korea has excellent infrastructure and in the near future the paradigm of pharmacovigilance will shift in Korea.

Learning objectives

The objective of this Workshop is to provide a common platform for regulatory authorities, academia, investigators, service providers and the Biopharmaceutical industry, to deliberate upon and understand PV Regulatory requirements and the most recent updates, impacting the Drug Safety spectrum. By providing case studies in the workshop, this would help participants how to apply the guidelines to their system and practices.

Registration Form

Program Committee

Kyung Won Seo Director General, National Institute of Food and Drug Safety Evaluation
Ministiry of Food and Drug Safety, Korea, Republic of
Chul Kim, MD, PhD Vice President
Samsung Bioepis, Korea, Republic of
Seungjae Baek Excutive Director
Hanmi Pharmaceuticals, Korea, Republic of
Junjeong Choi Associate Professor- Department of Pharmacy
Yonsei University College of Pharmacy, Korea, Republic of
Sanghee Kim Chief Executive Officer
Novotech Asia Korea Ltd., Korea, Republic of
MinJung Lim, MPharm Managing director
MediSafe, Pharmacovigilance Services, Korea, Republic of
Yongseok Ko Deputy Director NIFDS
Ministry of Food and Drug Safety (MFDS), Korea, Republic of
Eunah Paek Head of Medical Operation Group
Boryung Pharmaceutical Company, Korea, Republic of
SuWon Kim Pharmacovigilance Manager
Dong-A-ST, Korea, Republic of
HyeYoung Kim Medical Information & Pharmacoviglance
Chong Kun Dang Pharm, Korea, Republic of
Mijeong Kim, PhD Medical advisor
C&R Research Inc., Korea, Republic of
SoYeon Park Senior Drug Safety Manager
Celgene, Korea, Republic of
Hwayoung Lee Team Lead APAC
Pfizer Pharmaceuticals, Korea, Republic of