Electronic common technical document

Results: 446



#Item
101Research / Electronic Common Technical Document / Clinical Data Management / Clinical research / Medical informatics

EU Regulator eCTD Implementation Questionnaire

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Source URL: www.hma.eu

Language: English - Date: 2012-06-08 09:29:23
102Pharmaceutical industry / Clinical Data Management / Drug safety / European Medicines Agency / Electronic Common Technical Document / Pharmacovigilance / EMA / CD-ROM / Compact Disc / Clinical research / Research / Pharmaceutical sciences

NCAs and EMA requirements for submission of PSUR during the transitional period

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Source URL: www.ema.europa.eu

Language: English - Date: 2014-08-08 06:31:29
103Computer file formats / XML / Technical communication / Document Type Definition / Electronic Common Technical Document / Efficient XML Interchange / Computing / Web standards / Markup languages

EWG M2 Recommendation to the ICH Steering Committee Electronic Standards for the Transfer of Regulatory Information (ESTRI) File Format Recommendation – XML 10NOV2005 Title: XML Background:

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Source URL: estri.org

Language: English - Date: 2012-06-05 01:13:02
104Clinical Data Management / Clinical research / Electronic Common Technical Document

Requirements on Submissions (number and format) for New Applications within MRP, DCP and National Procedures Doc. Ref.: CMDhRev.15 OctoberApril 2015

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Source URL: www.hma.eu

Language: English - Date: 2015-04-29 10:02:09
105Electronic signage / Clinical Data Management / Clinical research / Electronic Common Technical Document

Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures Doc. Ref.: CMDhRev.13 OctoberApril 2015

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Source URL: www.hma.eu

Language: English - Date: 2015-04-29 10:02:09
106Medical informatics / Electronic Common Technical Document / Medicine / Pharmaceutical industry / European Medicines Agency / Clinical research / Research / Clinical Data Management

eCTD Implementation Survey Report – v4TIGes eCTD Implementation Survey Report By the Swedish Presidency of the EU

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Source URL: www.hma.eu

Language: English - Date: 2012-06-08 09:29:24
107Pharmaceutical industry / Health / Pharmaceutical sciences / European Medicines Agency / European Union law / Test data exclusivity / EudraLex / Electronic Common Technical Document / Clinical research / Pharmaceuticals policy / Research

PDF Document

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Source URL: www.cbg-meb.nl

Language: English - Date: 2015-04-16 23:41:56
108Medical informatics / Electronic Common Technical Document / Markup languages / Technical communication / Validator / XML / Computing / Clinical Data Management / Clinical research

Microsoft Word - EXTEDO_Reviewing_Validation_Tools

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Source URL: www.extedo.com

Language: English - Date: 2013-07-15 09:54:48
109Ethics / Research / Minutes / Agenda / Consensus decision-making / Electronic Common Technical Document / Human communication / Meetings / Parliamentary procedure / Clinical research

20 March 2015 EMA/CMDhCOORDINATION GROUP FOR MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES - HUMAN MEETING FINAL MINUTES (Version 4) of the meeting held onFebruary 2015

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Source URL: www.hma.eu

Language: English - Date: 2015-03-27 09:27:51
110Medical informatics / Electronic Common Technical Document / Medicine / Clinical research / Clinical Data Management / Research

Soutenance de Thèse Université Paris VI - SOLEIL Spécialité : Physico-Chimie Soutenance de Thèse

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Source URL: www.synchrotron-soleil.fr

Language: English - Date: 2015-02-18 06:59:24
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