1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
 |
About GHTF |  |
Steering Committee | |
Study Groups | |
GHTF Documents | |
Meetings & Training | |
Liaison Bodies | |
Newsroom |  |
| Presentor | Title | Link |
|---|---|---|
| Norris Alderson | NANOTECHNOLOGY AND U.S. PERSPECTIVES: FDA REPORT BY THE NANOTECHNOLOGY TASK FORCE |  |
| Sousan Altaie | Workshop G Biomarkers: Critical Path Through Science, Regulation And Common Sense | |
| Kathryn M. Carbone | Biomarkers for Medicines of the 21st Century: Complex Biological Products | |
| Egan Cobbold | Study Group 3 - Quality Systems: Status Report |
|
Quality Systems Auditing - The Canadian Experience |
|
|
| Karen A. Coleman | FDA’s MEDICAL DEVICE INSPECTION PROCESS | |
| Alfred M. Dolan | ISO 14971, 2007 Risk Management for all Medical Devices - The New Global Era | |
| Maria E. Donawa | Workshop - Regulatory Model for Development of Device Regulatory Systems - Global Harmonization: The Need | |
| Sherman Eagles | International standards and guidance that address Medical Device Software | |
| Björn Fahlgren | Regulatory Model for Development of Device Regulatory Systems - Needs, barriers and Constraints Associated With National Implementation - The way Forward…. | |
| Brian Fitzgerald | GHTF Software Ad Hoc |
|
Software Ad Hoc Mission |
|
|
| Maurice F.Freeman | UPDATE ON GLOBAL NOMENCLATURE (GMDN) OCTOBER 2007 | |
| Jorge Garcia | Study Group 2 Post-market Surveillance Status Report – October 2007 | |
| Julian M. Goldman | Update on Medical Device Interoperability and recommendations from GHTF 10 | |
| Federico Goodsaid | Biomarker Qualification and Clinical Trials | |
| Stephen Graves | Australian National Joint Replacement Registry - Post Market Surveillance of Joint Replacement Surgery | |
| Jeffrey L. Gren | Global Medical Device Regulation Harmonization Training | |
| Michael Gropp | Optimal Use of Experience Gained in Post-marketing Surveillance in Medical Device Regulatory Policy - Some personal reflections | |
| Antonio Hernandez | Medical Devices Regulation in Latin America and the Caribbean | |
| Sabina Hoekstra-van den Bosch | Nanotechnology in Medical Devices: EU Perspective | |
| Eamonn Hoxey | New Developments in the Standards Community – Quality Management & Sterilization |
|
| Francis Kalush | CDRH and Biomarkers: Strategies for the Development of In Vitro Diagnostics | |
| Larry Kessler | GHTF Training Initiative | |
| GHTF: Goals for the US-Canada Term as Chair 2007 – 2009 | |
|
| Susanne Ludgate | SG5: CLINICAL EVALUATION STATUS REPORT |
|
| OPTIMAL UTILISATION OF POST-MARKET DATA TO INFORM DEVICE REGULATION | |
|
| Sean Mac Curtain |
International Standards Organisation Conformity Assessment | |
| Subhas Malghan | Nanotechnology: The future appears to be much closer! | |
| Alfred E. Mann | Innovation in Healthcare: Balancing Patient Risk and Rewards | |
| Brian R. Matthews | Device-Drug Interface: The European Experience Attachment to Presentation |
|
| Ginette Y. Michaud | STUDY GROUP 1 Status Report |
|
| Needs, Barriers and Constraints Associated with National Implementation | |
|
| Shigetaka Miura | Industry view point on Software | |
| Robert M. Nelson | Clinical Device Trials in Countries with No Regulatory Systems | |
| Klaus Olejniczak | European Regulatory Bodies and Safety Biomarkers: what do they think? |
|
| Benny Ons | IVD devices incorporating Nanotechnologies: European Commission Report on Nanotechnologies in Medical Devices – Nanotechnologies and the IVD Directive | |
| Donald M. Powers | IVD Medical Device Standards: Increasing the Benefits, Reducing the Risks | |
| Kimber C. Richter | Harmonizing Regulations and Standards That Guide Clinical Investigation of Medical Devices | |
| Heather S. Rosecrans | FDA Product Codes & GMDN | |
| Nancy Shadeed | IVD Subgroup Study Group 1: Status Report | |
| Vera Sharav | Moral Principles or Expediency? | |
| Martin Shaw |
Novel Biomarkers of Early Kidney Damage in Drug Development | |
| Charles Sidebottom | Conformity Assessment to ISO 14971: A Key to the Kingdom | |
| Roger Snaith | Multi-Purpose Quality System Audits - The Australian Experience | |
| Shinichi Takae | Japan Quality Systems Auditing - Current and Future - | |
| Larry Tamarkin | PEGylated Colloidal Gold-TNF Nanomedicines | |
| Shelley Tang | Regulation of Combination Products – the Australian Approach | |
| Tomiko Tawaragi | HBD Project |
|
| Combination Products Regulation in Japan | |
|
| Anne Trimmer | GHTF Conference Workshop 1: Barriers | |
| Janet Trunzo | GHTF Steering Committee Update |
|
| Michel van der Heijden, Mark Hoyle, Tom Werthwine |
Unique Device Identification: The Role of GS1 Global Standards | |
| Jan Welch | GHTF Study Group 4 Regulatory Auditing - Overview of SG 4 Guidance Documents | |
| Hiroshi Yaginuma | Case study :Introduction of GHTF documents | |
| Chang Yongheng | Brief Introduction of Medical Device Regulations in China | |
| Markus Zobrist | Study Group 4 – “Regulatory Auditing” Status Report |
|
| Quality Systems Auditing for Multi-Purpose Inspections: Experience & Practical Advice-Giving | |
Updated 19 October 2007
|
GHTF Home | |
Site Map | |
Quick Links | |
Questions? | |
Site Feedback | |
Other Sites of Interest | |
Disclaimers | |