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Grand Hilton Seoul

Sep 06, 2019 8:00 AM - Sep 06, 2019 7:00 PM

201-1, Hongeun-dong, Seodaemun-gu, Seoul 120-710, Korea, Republic of

DIA- NIFDS Pharmacovigilance Workshop : Best Practices in Pharmacovigilance

Faculty

Kyung Won  Seo

Kyung Won Seo

Director General, National Institute of Food and Drug Safety Evaluation, Ministiry of Food and Drug Safety, Korea, Republic of

Dr. Kyung Won Seo is the Director General of the National Institute of Food and Drug Safety Evaluation at the Ministiry of Food and Drug Safety Korea since February 2021. Dr. Seo has involved in many toxicological research and studies and reviewed non-clinical data for 15 years. Dr. Seo was in charge of several divisions as Director including metabolic, reproductive and respiratory product; antibiotics and oncology product; and bioequivalence evaluation. Prior to her current position, Dr. Seo served as Director General of Pharmaceutical and Medical Device Research Department from 2015 to 2019.

Gerald  Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

Euna  Han

Euna Han

Professor, Yonsei University, Korea, Republic of

Hannah  Jeon

Hannah Jeon

Cluster Head APAC, Roche , Korea, Republic of

Yasufumi  Kuroda, PhD

Yasufumi Kuroda, PhD

Senior Director, Daiichi Sankyo Company, Limited, Japan

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, Pfizer R&D Japan G.K., Japan

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

Mohit  Raizada, DDS

Mohit Raizada, DDS

Director - Signal Management Services, IQVIA, India

Dr. Mohit Raizada is the Director and Head of Signal Management Services in the Lifecycle Safety department at IQVIA, India. He is an expert in signal management and has successfully onboarded, led, executed, and completed complex signal management projects for various companies. Mohit is currently leading the India Signal Management team and providing expert consulting on Signal Management projects for numerous companies, involving over 1000 marketed products. Mohit has 14 years of experience in Pharmacovigilance, including 10 years in Signal Management. He holds a bachelor's degree in dental surgery along with a Diploma in Clinical Research and Pharmacovigilance.

Dawn  Ren

Dawn Ren

Head of Therapeutic Area Speciality Medicine , Bayer Healthcare Company Limited, China

Shuya  Yoshida

Shuya Yoshida

Reviewer, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Chul  Kim, MD, PhD

Chul Kim, MD, PhD

Vice President, Samsung Bioepis, Korea, Republic of

Manabu  Akazawa

Manabu Akazawa

Professor Public Health and Epidemiology, Meiji Pharmaceutical University, Japan

Seungjae  Baek

Seungjae Baek

Excutive Director, Hanmi Pharmaceuticals, Korea, Republic of

Junjeong  Choi

Junjeong Choi

Associate Professor- Department of Pharmacy, Yonsei University College of Pharmacy, Korea, Republic of

Sanghee  Kim, PhD

Sanghee Kim, PhD

Head of Centralised Monitoring and RBQM, Novotech Asia Korea Ltd., Korea, Republic of

SangHee Kim is the Global Head of Centralized Monitoring & RBQM at Novotech. With over 30 years of experience in pharma (Sanofi) and CROs (Novotech), she has led clinical trial management, pharmacovigilance, and medical affairs. She holds a Pharmacy degree from ChungAng University and a PhD in Pharmacoepidemiology from SungKyunKwan University. She has also actively contributed to the clinical trial industry for over 15 years through KSCD.

Min-Jung  Lim, MPharm, RPh

Min-Jung Lim, MPharm, RPh

CEO & Senior Pharmacovigilance Consultant, MediSafe, Pharmacovigilance Services, Korea, Republic of

Min-Jung Lim is the CEO and Senior Pharmacovigilance Consultant at MediSafe, with over 25 years of experience in clinical research and pharmacovigilance. She previously led drug safety functions as Head of Pharmacovigilance & Post Marketing Studies at GSK Korea. She also serves as an Adjunct Professor at CHA University and Head of the Pharmacovigilance Division of the Korea Clinical Development Association. A licensed pharmacist in Korea, Ms. Lim holds a Master’s degree in Pharmacology. She has supported numerous pharmaceutical companies and bio-ventures in PV system development and risk management. She is an organizer of national training programs for pharmacovigilance professionals across regulatory and academic settings.

Yongseok  Ko

Yongseok Ko

Deputy Director NIFDS, Ministry of Food and Drug Safety (MFDS), Korea, Republic of

Eunah   Paek

Eunah Paek

Head of Medical Operation Group, Boryung Pharmaceutical Company, Korea, Republic of

SuWon  Kim

SuWon Kim

Pharmacovigilance Manager, Dong-A-ST, Korea, Republic of

HyeYoung  Kim

HyeYoung Kim

Medical Information & Pharmacoviglance, Chong Kun Dang Pharm, Korea, Republic of

Mijeong  Kim, PhD

Mijeong Kim, PhD

Medical advisor, C&R Research Inc., Korea, Republic of

SoYeon  Park

SoYeon Park

Senior Drug Safety Manager , Celgene, Korea, Republic of

Hwayoung  Lee

Hwayoung Lee

Team Lead APAC, Pfizer Pharmaceuticals, Korea, Republic of

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