Electronic Common Technical Document

Results: 446



#Item
1Pharmaceuticals policy / Pharmaceutical industry / Digital media / Research / Health / Agencies of the European Union / Medical research / Electronic submission / Marketing authorization / Heads of Medicines Agencies / Electronic common technical document

TIGes vet Q&A-update - Sept 2013

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:08
2Clinical data management / Clinical research / Health / Electronic common technical document / Evaluation / Pharmaceutical industry / Validation

Updated 08 JulyRelease Notes for the EU eCTD Validation Criteria version 6.1 The currently valid version of the eCTD validation criteria is version 6.1 and it needs to be applied as of 1 July 2016 in combination w

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:41
3Medical research / Clinical research / Health / Clinical data management / Computing / Electronic common technical document / Pharmaceutical industry / Pharmaceuticals policy / Marketing authorization / Section / Diff utility / Drug Master File

Release Notes for Harmonised Technical Guidance for eCTD Submissions in the EU v3.0 This document highlights the changes incorporated in version 3.0, in comparison with version 2.0, of the eCTD guidance document. For cle

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:10
4Pharmaceuticals policy / Health / Medical research / Clinical data management / Clinical research / Pharmaceutical industry / European Union / EudraLex / European Medicines Agency / Electronic common technical document / Common Technical Document / Marketing authorization

1 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:40
5Knowledge / Clinical data management / Clinical research / Electronic common technical document / Health / Research / Open access / Institutional repository

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 03:16:05
6Medical research / Clinical data management / Clinical research / Health / Pharmaceutical industry / Health informatics / Electronic common technical document / Pharmaceuticals policy / Marketing authorization / Committee for Medicinal Products for Human Use / Validation

PSUR Submissions in Single Assessment via EMA Gateway Webclient An agency of the European Union Presenters of the Day, from EMA

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:50
7Health / Agencies of the European Union / Clinical data management / Clinical research / Electronic common technical document / Digital media / European Medicines Agency / Knowledge / Filename / Computing / Form / Electronic submission

Error! No text of specified style in document. <> "Error*"eSubmission Gateway Web Client \* MERGEFORMAT eSubmission Gateway Web Client

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:59
8Medical research / Health / Clinical data management / Clinical research / Pharmaceuticals policy / European Medicines Agency / European Union / EudraLex / Electronic common technical document / Validation

eAF Question and Answers - update-KM_CPh-KP

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:02
9Computing / Data management / Software / ISO standards / Digital media / Research / Clinical data management / Electronic common technical document / Computer file / Portable Document Format / Directory structure / Folder

E-submission Guideline-Ver.2.0-Feb2011

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:51
10Digital preservation / Information technology / Computing / Information / Archival science / Records management / Digital libraries / Preservation / Open Archival Information System / Electronic common technical document / Enterprise content management / PDF/A

BAP_Appendix_v1 0_June 2013

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:06
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