Seong Ho Kim (Mr.)

Director,
Medical Devices Policy Division, Medical Device Safety Bureau,
KFDA

Day 1 > Keynote Speech

Kentaro Azuma (Mr.)

Deputy Director, Office of Medical Device Evaluation,
Pharmaceutical and Food Safety Bureau,
Ministry of Health, Labour and Welfare (MHLW)

Day 1 > Session 1

Kenichi Ishibashi (Mr.)

Inspector,
Office of GMP/QMS Inspection,
PMDA

Day 1 > Session 2-1

Jae-Ho Jung (Mr.)

Deputy Director,
Medical Device Quality Division,
KFDA

Day 1 > Session 2-2

Elisabeth George (Ms.)

VVice President,
Global Government Affairs, Regulations & Standards,
Philips Healthcare

Day 1 > Session 2-3

Nancy Shadeed (Ms.)

Manager,
Device Licensing Division,
Medical Devices Bureau, Health Canada

Day 1 > Session 3-1

Atsushi Tamura (Dr.)

Director,
Office of Medical Devices I,
PMDA, Japan

Day 1 > Session 3-2

Hiroshi Ishikawa (Mr.)

Vice Chair, GHTF committee /
Member, GHTF Steering Committee,
Japan Federation of Medical Devices Associations (JFMDA)

Day 1 > Session 3-3

Yutaka Tomioka (Mr.)

Reviewer,
Office of Medical Devices I,
PMDA

Day 1 > Session 4-1

Huifen Bai (Dr.)

Senior Regulatory Specialist,
Medical Device Branch,
Health Products Regulation Group, HSA

Day 1 > Session 4-2

Michael Flood (Mr.)

Principal,
Locus Consulting Pty Ltd.

Day 1 > Session 4-3

Michael Morton (Mr.)

Chair,
AdvaMed Premarket Approval (PMA) Working Group, AdvaMed /
US Industry Representative, GHTF SG1

Day 1 > Session 4-4

Yuka Sugamura (Ms.)

Officer,
Medical Device Safety Division & Medical Safety Information Group,
Office of Safety 1, PMDA

Day 2 > Session 5-1

Chadaporn (Miang) Tanakasemsub (Ms.)

AP QA/RA VP,
Zimmer

Day 2 > Session 5-2

Nancy Shadeed (Ms.)

Manager,
Device Licensing Division,
Medical Devices Bureau, Health Canada

Day 2 > Session 6-1

Atsushi Tamura (Dr.)

Director,
Office of Medical Devices I,
PMDA

Day 2 > Session 6-2

Rama Sethuraman (Dr.)

Senior Regulatory Specialist,
Medical Device Branch, Pre-Marketing Division,
Health Products Regulation Group, HSA

Day 2 > Session 6-3

Hae Dae Park (Mr.)

Senior Researcher,
Medical Device Evaluation Department,
KFDA

Day 2 > Session 6-4

Hiroshi Ishikawa (Mr.)

Vice Chair, GHTF committee /
Member, GHTF Steering Committee,
Japan Federation of Medical Devices Associations (JFMDA)

Day 2 > Session 7-1

Thomas Edward Werthwine (Mr.)

Global Process Owner,
Auto ID Technology and Data Standards,
Johnson & Johnson Health Care Systems / AdvaMed

Day 2 > Session 7-2

Tomomichi Nakazaki (Mr.)

Director,
Medical Devices Regulatory Affairs/Allergan Japan K.K.,
JFMDA

Day 2 > Session 7-3