2nd APEC Seminar Singapore

17-18 May 2002

Presentations

Session 1 - Welcome / Opening Address
Session 2 - Global Harmonization Task Force
Session 3 - The Global Medical Device Market and Regulatory Harmonization
Session 4 - Quality Systems
Session 5 - Post Market Surveillance
Session 6 - Harmonised Approaches to Medical Device Registration, Classification and Approval
Session 7 - Present and Proposed Implementation of GHTF Recommendations by Founding Members
Session 8 - Present and Proposed Implementation of GHTF Recommendations by APEC National Authorities
Session 9 - Round Table Discussion
Session 10 - Seminar Close

Global Harmonisation Task Force

Title / Author	Format	Size	Date Posted
Global Harmonization Task Force (GHTF) Rita Maclachlan - GHTF Chair; and Director Medical Devices Program Therapeutic Goods Administration, Australia	pdf	282Kb	12 July 2002

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The Global Medical Device Market and Regulatory Harmonisation

Title / Author	Format	Size	Date Posted
The Global Medical Device Market and Regulatory Harmonization M. B. Gropp - Guidant Corporation	pdf	Slides 1-15 1448Kb Slides 16-30 911Kb Slides 31-45 912Kb Slides 46-71 1399Kb	12 July 2002

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Quality Systems

Title/Author	Format	Size	Date Posted
Guidance for Auditing Markus Zobrist PhD, Inspector - Swissmedic, Swizerland, and Andrew Muir, Senior Auditor Conformity Assessment Branch, TGA, Australia	pdf	844Kb	12 July 2002
Design Control Guidance For Medical Device Manufacturers Egan Cobbold - Medical Devices Bureau Health, Canada	pdf	42Kb	12 July 2002
Audit Approaches Markus Zobrist, PhD, Inspector Swissmedic, Switzerland	pdf	42Kb	12 July 2002
Quality System Inspection Technique (QSIT) Robert L. Turocy	pdf	300Kb	12 July 2002
Quality Management Systems:.The Foundation for Regulatory Programs Tony Gould - Conformity Assessment Branch, TGA Australia	pdf	696Kb	12 July 2002
Process Validation Victor Dorman-Smith and Abbott Ireland	pdf	96Kb	12 July 2002
The Quality System Inspection Technique (QSIT) Christine Nelson - U.S. Food and Drug Administration	pdf	128Kb	12 July 2002
FDA QSIT Compared to European Notified Body (NB) Audit, Australia, Canada, Japan, etc. Robert L. Turocy	pdf	203Kb	12 July 2002
Quality Systems Standards Victor Dorman-Smith and Abbott Ireland	pdf	88Kb	12 July 2002

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Post Market Surveillance

Title / Author	Format	Size	Date Posted
Post Market Surveillance of Medical Devices Mr. Kim Dix, P. Eng - Head / Medical Devices Compliance National Coordination Centre, Health Products and Food Branch Inspectorate Health Canada	pdf	52Kb	12 July 2002
Global Harmonization Task Force - Study Group 2 Larry Kroger, Ph.D. Member, SG2	pdf	168Kb	12 July 2002
Medical Device Adverse Events: What Information, by When and.to Whom to Report and The Vigilance Exchange Program - GHTF Study Group 2 Jorge E Garcia, Ph.D. Member, SG2 (representing TGA, Australia)	pdf	53Kb	12 July 2002

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Harmonised Approaches to Medical Device Registration, Classification and Approval

Title / Author	Format	Size	Date Posted
Medical Devices - Regulations, Standards Risk Management, Global Harmonisation Maurice Freeman, Chair SG1 of GHTF	pdf	73Kb	12 July 2002
Medical Device Regulation - Control Based on Risk Fred S. Halverson Medtronic, Inc. Minneapolis, Minnesota	pdf	60Kb	12 July 2002

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Present and Proposed Implementation of GHTF Recommendations by Founding Members

Plenary Session 3 presentations from the 9th Conference

Representatives from the GHTF Founding Member regulatory authorities repeated "The Score Card" presentations delivered by Members of the GHTF Steering Committee on Thursday, 17 May 2002 during Plenary Session 3 of the 9th GHTF Conference.

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Present and Proposed Implementation of GHTF Recommendations by APEC National Authorities

Title / Author	Format	Size	Date Posted
AHWP Technical Committee Survey Report 2002	pdf	405Kb	12 July 2002
Recent Developments of Medical Device Regulation in Taiwan Hsiau-Wen Huang, Ph.D. - Senior Researcher Bureau of Pharmaceutical Affairs Department of Health, Taiwan, R.O.C.	pdf	843Kb	12 July 2002