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Pharmacovigilance

Workshop

Hyun-Cheol Jeong 

  • Hyun-Cheol Jeong Pharmaceutical Safety Evaluation Division, MFDS
    • Day 1 > Opening Ceremony
      • Kenote Speech
    • Day 2 > Session II
      • Updates on APEC Phamracovigilance Roadmap
    • Day 2 > Session III (Panelist)

Sun Young Jeong 

  • Sun Young Jeong Principal Researcher, Office of Pharmacoepidemiology, KIDS
    • Day 1 > Session I (Chair)

Daisuke Tanaka 

  • Daisuke Tanaka Technical Officer, Safety & Vigilance: Medicines, Essenstial Medicines and Health Products, WHO
    • Day 1 > Session I
      • Role and Importance of Pharamcovigilance in Global Public Health
    • Day 1 > Session II (Chair)
    • Day 2 > Session II (Chair/Panelist)

Anki Hagstrom 

  • Anki Hagstrom Head, Global Services, UMC
    • Day 1 > Session I
      • WHO-UMC Activities on Pharmacovigilance
    • Day 1 > Session III (Chair)
    • Day 2 > Session I (Panelist)

Gerald J. Dal Pan 

  • Gerald J. Dal Pan Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. FDA
    • Day 1 > Session I
      • ICH Activities on Pharmacovigilance
    • Day 1 > Session III
      • Re-developement of ICH E2B (R2&R3): Introduction and key issues
    • Day 1 > Session IV (Chair)
      • Wrap up and Conclusion
    • Day 2 > Session III (Chair/Panelist)
      • Wrap up and Conclusion

Lanette Lee A. Querubin 

  • Lanette Lee A. Querubin Food-Drug Regulation Officer III, Center for Drug Regulation and Research, Philippines FDA
    • Day 1 > Session II
      • Issues and Challenges of Pharmacovigilance Harmonization - Regulatory Perspective
    • Day 2 > Session III (Panelist)

Si-Nae Lee 

  • Si-Nae Lee Head, Country PV, Pacific Rim, BMS
    • Day 1 > Session II
      • Issues and Challenges of Pharamcovigilance Harmonization - Pharamceutical Industry's Perspective

Jin-Ho Lee 

  • Jin-Ho Lee Professor, Department of Gastroenterology & Hapatology, Dongguk International University Hospital
    • Day 1 > Session II
      • Issues and Challenges of Pharmacovigilance Harmonization - Academia's perspective

Shusen Liu 

  • Shusen Liu Head, Pharamcoepidemiology Asia Pacific, MRL
    • Day 1 > Session IV
      • 'Risk-Benefit Assessement' in Pharmacovigilance

Maria de la luz Lara Mendez 

  • Maria de la luz Lara Mendez Executive Director, Pharmacopoeia and Pharmacovigilance, COFEPRIS
    • Day 2 > Session I (Panelist)
      • Current Status and Policy Direction on "Adverse Event Reporting" - Mexico

Wen-Wen Chen 

  • Wen-Wen Chen Deputy CEO, Taiwan Drug Relief Foundation
    • Day 2 > Session I (Chair/Panelist)
      • Current Status and Policy Direction on "Adverse Event Reporting" - Chinese Taipei

Bon-Ki Koo 

  • Bon-Ki Koo President, KIDS
    • Day 2 > Session I (Panelist)

Magaly Tito Yepez 

  • Magaly Tito Yepez Chief, Pharmacoepidemiology and Pharmacovigilance, DIGEMID
    • Day 2 > Session I (Panelist)

Wimon Suwankesawong 

  • Wimon Suwankesawong Head, Health Product Vigilance Center, Thai FDA
    • Day 2 > Session II (Panelist)
      • Current Status and Policy Direction on "Adverse Event Evaluation" - Thailand

Nafiza Mohd Ismail 

  • Nafiza Mohd Ismail Principal Assistant Director, Centre for post-registration of products,
    National Pharmaceutical Control Bureau, MoH Malaysia
    • Day 2 > Session II
      • Current Status and Plicy Direction on "Adverse Event Evaluation" - Malaysia

Niwa Shimpei 

  • Niwa Shimpei Manager, Safety and Risk Management Department, Daiishi Sankyo Co., Ltd.
    • Day 2 > Session II (Panelist)

Norleen Mohamed Ali 

  • Norleen Mohamed Ali Senior Prinicipal Assistant Director, National Pahrmaceutical Control Bureau, MoH Malaysia
    • Day 2 > Session II (Panelist)

Siti Asfijah Abdoellah 

  • Siti Asfijah Abdoellah Head, Directorate of Distribution Control of Therapeutic Products, NADFC Indonesia
    • Day 2 > Session III (Panelist)
      • Current Status and Policy Direction on "Decision Making and Risk Communication" - Indonesia

Dorothy Toh 

  • Dorothy Toh Acting Assistant Group Director, Health Regulation Group, HSA
    • Day 2 > Session III
      • Current Status and Policy Direction on "Decision Making and Risk Communication" - Singapore

Training Program (Closed Meeting)

Anki Hagstrom 

  • Anki Hagstrom Head, Global Services, UMC
    • Day 1 > Session I
      • Introduction to Pharmacovigilance
      • Pharmacovigilance Methods
    • Day 2 > Monitoring in Special Fields
      • Adverse Event Monitoring on SSFFC

Sooyoun Chung 

  • Sooyoun Chung Executive Principal Researcher/Director, Office of Drug Safety Information (1), KIDS
    • Day 1 > Session II
      • Implementing Pharmacovigilance at National Level

Gerald J. Dal Pan 

  • Gerald J. Dal Pan Director, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. FDA
    • Day 1 > Session II
      • Understanding Global Guidelines of Pharmacovigilance
    • Day 2 > Session IV
      • Causality Assessment of ICSR
    • Day 3 > Session V
      • Decision Making (Regulatory Action)

Magnus Wallberg 

  • Magnus Wallberg Technology Evangelist, Product Development Quality, UMC
    • Day 1 > Session III
      • Managing ICSRs and data exchange in a global PV environment

Malin Jakobsson
 

  • Malin Jakobsson Product Manager, Product Management, UMC
    • Day 1 > Session III
      • The benefit of using standard terminologies in ICSR management

Yeonju Woo 

  • Yeonju Woo Senior Researcher, Office of Drug Safety Information (1), KIDS
    • Day 1 > Session III
      • Implementing Adverse Event Resporting System (DB)

Sujin Kim 

  • Sujin Kim Senior Researcher, Office of Drug Safety Information (1), KIDS
    • Day 2 > Session IV
      • Single Detection and Drug Safety Information Generation

Masaki Sanekata 

  • Masaki Sanekata Activity Member, Post Marketing Surveillance Committee, JPMA
    • Day 2 > Monitoring in Special Fields
      • Monitoring on Antimicrobial Resistance

Min Chen 

  • Min Chen Senior Scientific Advisor, TFDA
    • Day 3 > Session V
      • Decision Making (Regulatory Action)
      • Overview of Risk Management
      • Risk Communication

Ho-Jeong Kim 

  • Ho-Jeong Kim Deputy Director, Cardiovascular & Neurology Products Division Drug Evaluation Department, MFDS
    • Day 3 > Session V
      • Overview of Risk Management

Adena Lim 

  • Adena Lim Deputy Director, Vigilance and Compliance Branch, HSA
    • Day 3 > Session V
      • Risk Communication