Home > Training Program > 2010 Third Workshop > Program
November 15, 2010 (Monday)
Understanding and implementation of GHTF guidance on clinical evidence for premarket conformity assessment
| 09:00 ~ 09:20 |
Opening Ceremony
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|---|---|
| 09:20 ~ 09:50 |
Keynote Speech : Regulatory System of Medical Devices in Korea
SpeakerEun-Sook Jhon (Director, Medical Device Safety Bureau, KFDA) |
| 09:50 ~ 10:30 |
Difference Between Clinical Evidence of Medical Device and Pharmaceuticals from Regulatory Perspective
SpeakerMing-Chun Tsai (Chinese Taipei FDA) |
| 10:50 ~ 11:30 |
Overview of GHTF Regulatory Model
SpeakerMichael Gropp (Medtronic, GHTF Steering Committee) |
| 11:30 ~ 12:20 |
Overview of GHTF/SG1 Activities & GHTF/SG5 Key Definitions
SpeakerAtsushi Tamura (PMDA, Japan) |
| 14:00 ~ 14:50 |
Focus on Clinical Evaluation (GHTF SG5/N2R8:2007)
SpeakerGreg LeBlanc (Cook Inc.) |
| 14:50 ~ 15:40 |
Focus on Clinical Evaluation (GHTF SG5/N2R8:2007)
SpeakerKathy Harris (Johnson & Johnson) |
| 16:00 ~ 16:50 |
Requirements and Suggestions for Clinical Trial Investigations
SpeakerHerbert Lerner (US FDA) |
| 16:50 ~ 17:40 |
Post-Marketing Clinical Follow-up Studies (GHTF SG5 N4:2010)
SpeakerMadoka Murakami (PMDA, Japan) |
November 16, 2010 (Tuesday)
Understanding the infrastructure needed in supporting clinical trial which is designed and conducted ethically and scientifically when it is required for premarket conformity assessment, building confidence on clinical data generated in other jurisdictions
| 09:20 ~ 09:30 |
Recap of the 1st day SpeakerMichael Gropp (Medtronic, GHTF Steering Committee) |
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| 09:30 ~ 12:20 |
Clinical Investigation Policies in major countries focus on recent clinical investigation policy including acceptance of the foreign clinical data ModeratorTran Quan (AHWP SG5 Co-Chair) SpeakerJapan - Mami Ho (PMDA) (09:30 – 10:10) Korea - Hea-Young Cho (KFDA) (10:10 – 10:50) Chinese Taipei-Ming-Che Wang(CDE, Chinese Taipei)(10:50–11:30) United States - Carole Carey (USFDA) (11:30 – 12:10)
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| 13:30 ~ 14:20 |
Clinical Trial Design in Medical Device Clinical Trial to meet Regulatory Requirements on Premarket Conformity Assessment SpeakerStephen Rhodes (Biologics Consulting Group / FDAAA)
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| 14:20 ~ 15:10 |
Focus on Good Clinical Practices for Medical Device Clinical Investigations SpeakerNeal Fearnot (Cook Medical)
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| 15:10 ~ 16:00 |
Multiregional Clinical Trial Corporation: Opportunity and Challenges SpeakerCarole Carey (USFDA)
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| 16:20 ~ 17:00 | Panel Discussion and Q&A |
| 17:00 ~ | Group Photo Session & Closing |
