1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
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Working Towards Harmonization in Medical Device Regulation |
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Additional presentations from the 8th GHTF Conference will be posted here as they become available. Note that the latest additions are highlighted with a pink background. Use the menu below to go the appropriate session from the Conference.
Plenary Session - Americas Issues
Meeting - ISO FDIS 9001 Information Update
Study Group 2 Information Update - MRA
Update
Panel
Sessions PVC - Reuse of Single-Use
Medical Devices - Device Nomenclature
Posted
15 October 2000
One additional PVC presentation
Posted
21 October 2000
One additional Reuse presentation
Posted
23 October 2000
One additional Americas Issues Meeting
presentation (Brazil)
Posted
24 October 2000
One additional Device
Nomenclature
presentation
Plenary Session
Presentations are listed in the order they were delivered
during the Plenary Session.
| Title / Author | Format | Size | Date Posted |
| Presentation
on Guiding Principles Document - Dr. Elizabeth Jacobson, CDRH |
Powerpoint | 56Kb | 11 October 2000 |
| Presentation
on Operating Procedures Document - Mr. Michael Baker, EUCOMED |
Powerpoint | 284Kb | 11 October 2000 |
| SG2
Report - Dr. Larry Kessler, Chair of SG 2 |
Powerpoint | 13Kb | 11 October 2000 |
| SG3
Report - Ms. Kim Trautman, Chair of SG 3 |
Powerpoint | 45Kb | 11 October 2000 |
| SG4
Report - Mr. Robert Allen, Chair of SG 4 |
Powerpoint | 81Kb | 11 October 2000 |
| Americas
Update - Mr. Antonio Hernandez, PAHO |
Word | 24Kb | 11 October 2000 |
| Asia
Harmonization Working Party Update - Dr. Clarence Tan, Singapore Ministry for Health |
Word | 26Kb | 11 October 2000 |
| Recent
Developments in the Medical Devices Regulations in Taiwan - Dr. Oliver Yoa-Pu Hu, Taiwan Department of Health |
Powerpoint | 472Kb | 11 October 2000 |
| Implementation
of the GHTF- ISO/TC 210 Memorandum of Understanding - Mr. Robert Allen, Chair of ISO/ TC 210 and Chair of SG 4 |
Powerpoint | 110Kb | 11 October 2000 |
| Country / Organization | Format | Size | Date Posted |
| Argentina (in Spanish) | Powerpoint | 290Kb | 11 October 2000 |
| Brazil | Powerpoint | 146Kb | 23 October 2000 |
| Chile (in Spanish) | Powerpoint | 281Kb | 11 October 2000 |
| Costa Rica | Powerpoint | 80Kb | 11 October 2000 |
| Cuba | Powerpoint | 183Kb | 11 October 2000 |
| Dominican Republic | Powerpoint | 242Kb | 11 October 2000 |
| Ecuador (in Spanish) | Word | 115Kb | 11 October 2000 |
| PAHO (Pan-American Health Organization) | Powerpoint | 112Kb | 11 October 2000 |
| Peru (Notes from a planned presentation which was not actually delivered at the Conference.) | Word |
25Kb |
11 October 2000 |
| Trinidad & Tobago | 523Kb | 11 October 2000 | |
| WHO (World Health Organization) | Powerpoint | 110Kb | 11 October 2000 |
| Title / Author | Format | Size | Date Posted |
| FDA/EU
Mutual Recognition Agreement Update - Christine Nelson |
Powerpoint | 116Kb | 11 October 2000 |
ISO FDIS 9001 Information Update
| Title / Author | Format | Size | Date Posted |
| Accomplishments
of TC210 Representatives - Edward Kimmelman |
Powerpoint | 75Kb | 11 October 2000 |
| ISO
13485:2002 Forecast - Pierre Landry |
Powerpoint | 107Kb | 11 October 2000 |
| Changes
to FDIS 9001:2000 - Kimberly A. Trautman |
Powerpoint | 43Kb | 11 October 2000 |
Study Group 2 Information Update
| Title / Author | Format | Size | Date Posted |
| Overview
of SG2 - Deb Blum |
Powerpoint | 127Kb | 11 October 2000 |
| Pilot
Vigilance Exchange Program - Kim Dix |
Powerpoint | 1166Kb | 11 October 2000 |
| SG2
N21 Manufacturer Reporting Guidance - Ben Khosravi |
Powerpoint | 65Kb | 11 October 2000 |
|
Introduction
to Key Projects |
Powerpoint | 53Kb | 11 October 2000 |
| Title / Author | Format | Size | Date Posted |
| PVC
and DEHP: FDA Assessment - David W. Feigal, M.D., M.P.H. |
Powerpoint | 211Kb | 15 October 2000 |
| PVC/DEHP
in Medical Products: Challenges and Opportunities - Jon Cammack, PhD |
Powerpoint | 268Kb | 11 October 2000 |
| CERHR’s
Review of the Human Reproductive and Developmental Toxicity of Phthalate
Esters - Tim Zacharewski |
Powerpoint | 57Kb | 11 October 2000 |
|
DEHP
in Medical Devices |
Word |
54Kb | 11 October 2000 |
Panel Session: Reuse of Single-Use
Medical Devices
| Title / Author | Format | Size | Date Posted |
| FDA
and the Reuse of Single Use Devices: Policy Now Established - Larry Kessler, PhD |
Powerpoint | 73Kb | 11 October 2000 |
| Update
on Reuse of Single-Use Medical Devices in Canada - Philip D. Neufeld, PhD |
Powerpoint |
135Kb | 11 October 2000 |
| Reuse
of Single Use Devices - Peter Schröer, PhD |
321Kb | 21 October 2000 |
Panel Session: Device Nomenclature
| Title / Author | Format | Size | Date Posted |
| Generating
the GMDN : Process & Regulatory Considerations - Sharon F. Dillard |
Powerpoint | 116Kb | 11 October 2000 |
| Global
Medical Device Nomenclature (GMDN) - Robert Allen |
Powerpoint | 157Kb | 24 October 2000 |
Updated 22 July 2004
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