Common Technical Document

Results: 587



#Item
21Medical research / Clinical data management / Health / Clinical research / Computing / Network protocols / Electronic common technical document / Pharmaceutical industry / EudraPharm / Change request / Change control board / RDM

EU Change Control Process for Change Requests in the Entire Area of Electronic Submissions for Human Medicinal Products Version 2.1 May 2011

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:47
22Medical research / Clinical data management / Clinical research / Health / Electronic common technical document / Digital media / Research / Common Technical Document / European Medicines Agency / Electronic submission / Form / EMA

eSubmission Gateway / Web Client to become mandatory for all eCTD submissions through the centralised Procedure in 2014 <> "Error*"eSubmission Gateway / Web Client to become mandatory for all eCTD submissions through th

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:51
23Medical research / Clinical research / Clinical data management / Health / Computing / Pharmaceuticals policy / Electronic common technical document / Markup languages / Common Technical Document / Marketing authorization / Pharmacovigilance / Document type definition

EU Module 1 eCTD Specification Version 3.0 October 2015 Document Control

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:42
24Computing / Software / Archive formats / Clinical data management / Clinical research / Electronic common technical document / Computer file formats / Filename / Zip / Ar / Naming convention / Form

EMAAnnex 3. January 2015

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:59
25Computing / Medical research / Clinical research / Clinical data management / Data / Markup languages / Electronic common technical document / Open formats / Common Technical Document / Marketing authorization / Portable Document Format / OPML

EU Module 1 Specification VersionNovember 2011 Document Control

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:45
26Medical research / Pharmaceutical industry / Health / Clinical data management / Health informatics / Clinical research / Electronic common technical document / Pharmaceuticals policy / Marketing authorization

Gateway user guide xml delivery files

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:47
27Computing / Health / Clinical data management / Clinical research / Data / Electronic common technical document / Markup languages / Computer file formats / European Medicines Agency

Submissions to the PSUR Repository using EMA Gateway/Web Client

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:01
28Clinical data management / Clinical research / Universal identifiers / Identifiers / Quality / Health / Evaluation / Value / Electronic common technical document / Universally unique identifier / Validation / Globally unique identifier

Implementation guide for EU eCTD M1 specification

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:07
29Computing / Clinical data management / Clinical research / Data / Pharmaceutical industry / Health / Electronic common technical document / Publishing / Readability / Validation

Release Notes for Harmonised Technical Guidance for NeeS Submissions in the EU v4.0 This document highlights the changes made in version 4.0 in comparison with version 3.0 of the “Harmonised Technical Guidance for Non-

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:07
30Computing / Data / Markup languages / Computer file formats / Clinical data management / Clinical research / Electronic common technical document

Submissions to the PSUR Repository using EMA Gateway/Web Client

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:10
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