Global Harmonization Task Force

Results: 752



#Item
511Science / Pharmaceutical industry / Validity / Quality / Global Harmonization Task Force / Medical device / Validation / Verification and validation / Functional Safety / Technology / Medicine / Medical equipment

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/N011:2008 Summary Technical Documentation

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:36
512IVD / Global Harmonization Task Force / Medical device / Science / Documentation / Protocol / Medical equipment / Technology / Medical technology

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of IVD Medical Devices (STED) Study Group 1 Final Document GHTF/SG1/SG1/N063:2011 Summary Technical Docum

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:37
513Research / Clinical research / Asia-Pacific Economic Cooperation / Pharmaceutical industry / Clinical pharmacology / Global Harmonization Task Force / Clinical trial / Food and Drug Administration / Pharmaceutical sciences / Pharmacology / Health

Microsoft Word - PMDA Updates_September_100930 .doc

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Source URL: www.pmda.go.jp

Language: English - Date: 2010-10-20 06:12:49
514Pharmacy / Medical equipment / Drug safety / Global Harmonization Task Force / Pharmacovigilance / Clinical research / Drug discovery / Medical device / Pharmaceutical industry / Pharmaceutical sciences / Medicine / Pharmacology

PMDA Updates June, 2011 News 1. GHTF Steering Committee (May 10 to 13) As Japan’s regulatory authority, PMDA and MHLW sent their representatives to GHTF

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Source URL: www.pmda.go.jp

Language: English - Date: 2011-06-16 20:09:45
515Medical equipment / Pharmacology / Food and Drug Administration / Pharmaceuticals policy / Pharmaceutical industry / Global Harmonization Task Force / Medical device / Unique Device Identification / European Medicines Agency / Medicine / Health / Pharmaceutical sciences

Microsoft Word - 英語版PMDA Updates10月号(確定1).docx

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Source URL: www.pmda.go.jp

Language: English - Date: 2012-10-29 23:53:42
516Health / Global Harmonization Task Force / Medical device / Adverse event / Food and Drug Administration / Medicine / Medical equipment / Technology

GHTF SG2 68R3:2005 Summary of Current Requirements for Where to Send Adverse Event Reports. Study Group 2 – Final Status Document GHTF SG2 68R3:2005 Summary of Current Requirements for Where to Send Adverse Event Repor

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:51
517Research / Technology / Medical equipment / Pharmacology / Global Harmonization Task Force / Adverse event / Clinical trial / Serious adverse event / Medical device / Clinical research / Pharmaceutical industry / Medicine

Reportable Events During Pre-Market Clinical Investigations Study Group 5 Final Document GHTF/SG5/N5:2012 Reportable Events During Pre-Market Clinical Investigations Study Group 5 Final Document GHTF/SG5/N5:2012

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:53:15
518Technology / Global Harmonization Task Force / Medical device / XML / Adverse event / Medical equipment / Medicine / Computing

An XML schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (based on GHTF/SG2/N54:[removed]Study Group 2 Final Document GHTF/SG2/N8

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:52
519National Center for Atmospheric Research / Medical device / Medical equipment / Global Harmonization Task Force / Technology

Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program GHTF SG2 N38R19:2009 – Study Group 2 - Final Document GHTF/SG2/ N38R19:2009

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:49
520Global Harmonization Task Force / Medical device / Therapeutic Goods Administration / Regulation / Medicine / Medical equipment / Technology

Message from Outgoing Australian Chair My time as Australian Chair of the Global Harmonization Task Force (GHTF) over the past 18 months has coincided with an interesting time in the international world of medical devic

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:17
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