skip to content

2018 Pharmacovigilance CoE

Speakers

Eun-Sook Jhon (Dr.)

  • Eun-Sook Jhon (Dr.)
    • Director General
    • Medical Device Safety Bureau
    • Korea Food and Drug Administration (KFDA)
    • US FDA
  • Keynote

Ming-Chun Tsai (Mr.)

  • Ming-Chun Tsai (Mr.)
    • Senior Reviewer
    • Division of Medical Devices and Cosmetics
    • FDA Chinese Taipei
  • Day 1 > Session 1

Michael Gropp (Mr.)

  • Michael Gropp (Mr.)
    • Vice President
    • Global Regulatory Strategy, Medtronic Inc.
    • GHTF Steering Committee
  • Day 1 > Session 2

Atsushi Tamura (Dr.)

  • Atsushi Tamura (Dr.)
    • Director
    • Office of Medical Devices II
    • PMDA
  • Day 1 > Session 3

Greg LeBlanc (Dr.)

  • Greg LeBlanc (Dr.)
    • Manager
    • Regulatory Affairs and Quality Systems
    • Cook Canada Inc.
    • GHTF SG5 Vice Chair
  • Day 1 > Session 4

Kathy Harris (Ms)

  • Kathy Harris (Ms)
    • Director
    • Regulatory Affairs
    • Johnson & Johnson Company
  • Day 1 > Session 5

Herbert Lerner (Dr.)

  • Herbert Lerner (Dr.)
    • Division Director
    • Division of Reproductive
    • Gastro-Renal and Urological Devices
    • US FDA/CDRH/ODE
  • Day 1 > Session 6

Madoka Murakami  (Ms)

  • Madoka Murakami (Ms)
    • Reviewer
    • Office of Medical Devices I
    • PMDA
  • Day 1 > Session 7

Tran Quan (Ms)

  • Tran Quan (Ms)
    • Executive, Quality Assurance & Regulatory Affairs (QARA)
    • GE Healthcare Asia Pacific
    • AHWP SG5 Co Chair
  • Day 2 > Session 1

Mami Ho (Dr.)

  • Mami Ho (Dr.)
    • Deputy Review Director
    • Office of Medical Devices I
    • PMDA
  • Day 2 > Session 1-1

Hea-Young Cho (Dr.)

  • Hea-Young Cho (Dr.)
    • Deputy Director
    • Clinical Trials Management Division
    • Risk Prevention Policy Bureau
    • Korea Food and Drug Administration (KFDA)
  • Day 2 > Session 1-2

Ming-Che Wang (Dr.)

  • Ming-Che Wang (Dr.)
    • Director
    • Division of Medical Devices
    • Center for Drug Evaluation (CDE), Taiwan
  • Day 2 > Session 1-3

Carole Carey (Ms.)

  • Carole Carey (Ms.)
    • Director, International Staff
    • Division of Small Manufacturers
    • International and Consumer Assistance
    • US FDA/CDRH
  • Day 2 > Session 1-4
  • Day 2 > Session 4

Stephen Rhodes (Mr.)

  • Stephen Rhodes (Mr.)
    • Senior Consultant
    • Medical Devices Biologics Consulting Group, Inc.
    • FDAAA
  • Day 2 > Session 2

Neal Fearnot (Dr.)

  • Neal Fearnot (Dr.)
    • Vice President
    • Cook Medical Inc.
  • Day 2 > Session 3