GHTF 11th Conference At A Glance

PAHO/Latin America - Ronald Reagan Building, Room: Oceanic A

Asia Harmonization Working Party - Ronald Reagan Building, Room: Oceanic B

Topical Workshops

Ronald Reagan Building

Workshop A: Regulatory Model for Development of Device Regulatory Systems: Needs, Barriers and Constraints Associated with National Implementation

Room: Meridian C

Maria E. Donawa - Global Harmonization: The Need

Björn Fahlgren - Needs, barriers and Constraints Associated With National Implementation - The way Forward….

Ginette Y. Michaud - Needs, Barriers and Constraints Associated with National Implementation - The Present Situation

Anne Trimmer - GHTF Conference Workshop 1: Barriers

Hiroshi Yaginuma - Case study :Introduction of GHTF documents

Chang Yongheng - Brief Introduction of Medical Device Regulations in China

Workshop B: Quality Systems Auditing for Multi-Purpose Inspections: Experience and Practical Advice-Giving

Room: Meridian D

Egan Cobbold - Quality Systems Auditing - The Canadian Experience

Shinichi Takae - Japan Quality Systems Auditing- Current and Future

Markus Zobrist - Quality Systems Auditing for Multi-Purpose Inspections: Experience & Practical Advice-Giving

Karen A. Coleman - FDA’s MEDICAL DEVICE INSPECTION PROCESS

Roger Snaith - Multi-PurposeQuality System Audits - The Australian Experience

Jan Welch - GHTF Study Group 4 Regulatory Auditing - Overview of SG 4 Guidance Documents

Workshop C: Emergence of Nanotechnology and its Impact on Device Regulatory Harmonization

Room: Meridian E

Subhas Malghan - Nanotechnology:The future appears to be much closer!

Norris Alderson - NANOTECHNOLOGY AND U.S. PERSPECTIVES: FDA REPORT BY THE NANOTECHNOLOGY TASK FORCE

Sabina Hoekstra-van den Bosch - Nanotechnology in Medical Devices:  EU Perspective

Benny Ons - IVD devices incorporating Nanotechnologies: European Commission Report on Nanotechnologies in Medical Devices – Nanotechnologies and the IVD Directive

Larry Tamarkin - PEGylated Colloidal Gold-TNF Nanomedicines

Workshop D: New Developments in the Standards Community

Room: Meridian D

Alfred M. Dolan - ISO 14971, 2007 Risk Management for allMedical Devices - The New Global Era

Eamonn Hoxey - New Developments in the Standards Community –
Quality Management & Sterilization

Sean Mac Curtain - International Standards Organisation Conformity Assessment

Donald M. Powers - IVD Medical Device Standards: Increasing the Benefits, Reducing the Risks

Kimber C. Richter - HarmonizingRegulations and Standards That Guide Clinical Investigationof Medical Devices

Charles Sidebottom - Conformity Assessment to ISO 14971:A Key to the Kingdom

Workshop E: Regulatory Considerations of Medical Device Software

Room: Oceanic A

Sherman Eagles - International standards and guidance that address Medical Device Software

Brian Fitzgerald - Software Ad Hoc Mission

Shigetaka Miura - Industry view point on Software

Workshop F: Regulation of Combination Products with ICH Perspectives

Room: Oceanic B

Shelley Tang - Regulation of Combination Products – the Australian Approach

Brian R. Matthews - Device-Drug Interface: The European Experience
Attachment to Presentation

Tomiko Tawaragi - Combination Products Regulation in Japan

Workshop G: Biomarkers: Critical Path through Science, Regulation & Common Sense

Room: Meridian C

Sousan Altaie - Workshop GBiomarkers: Critical Path Through Science, Regulation And Common Sense

Kathryn M. Carbone - Biomarkers for Medicines of the 21st Century: Complex Biological Products

Federico Goodsaid - Biomarker Qualification and Clinical Trials

Francis Kalush - CDRH and Biomarkers: Strategies for the Development of In Vitro Diagnostics

Klaus Olejniczak - European Regulatory Bodies and Safety Biomarkers: what do they think?

Martin Shaw - Novel Biomarkers of Early Kidney Damage in Drug Development

Workshop H: Clinical Trials in Countries with No Device Regulatory System: Ethics and Legalities

Room: Meridian E

Robert M. Nelson - Clinical Device Trials in Countries with No Regulatory Systems

Vera Sharav - Moral Principles or Expediency?

Workshop I: Optimal Utilization of Post-Market Data to Inform Device Regulation

Room: Oceanic A

Stephen Graves - Australian National Joint Replacement Registry - Post Market Surveillance of Joint Replacement Surgery

Susanne Ludgate - OPTIMAL UTILISATION OF POST-MARKET DATA TO INFORM DEVICE REGULATION

Michael Gropp - Optimal Use of Experience Gained in Post-marketing Surveillance in Medical Device Regulatory Policy - Some personal reflections

Workshop J: Device Identification and Global Nomenclature

Room: Oceanic B

Maurice F.Freeman - UPDATE ON GLOBAL NOMENCLATURE (GMDN)OCTOBER 2007

Heather S. Rosecrans - FDA Product Codes & GMDN

Michel van der Heijden, Mark Hoyle, Tom Werthwine - Unique Device Identification: The Role of GS1 Global Standards

Workshop K: Regulatory Model for Development of Device Regulatory Systems: Needs, Barriers and Constraints Associated with National Implementation

Room: Meridian A

See Presentations for Workshop A

Workshop L: Quality Systems Auditing for Multi-Purpose Inspections: Experience and Practice Advice-Giving

Room: Meridian D

See Presentations for Workshop B

Workshop M: Emergence of Nanotechnology and its Impact on Device Regulatory Harmonization

Room: Meridian E

See Presentations for Workshop C

AdvaMed Reception, 6:00-8:00 PM

US Botanic Gardens
100 Maryland Ave., SW
Washington, DC
(Personal transportation required)