Common Technical Document

Results: 587



#Item
31Medical research / Health / Pharmaceuticals policy / Clinical research / Pharmaceutical industry / European Union / Pharmacopoeias / European Medicines Agency / European Pharmacopoeia / Marketing authorization / Electronic common technical document / Adobe LiveCycle

Technical User Guide eAF hum-vet version20151001-clean

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:01
32Clinical data management / Clinical research / Health / Knowledge / Research / Electronic common technical document / European Medicines Agency / Institutional repository / Version control / Common Technical Document

Q & A for EMA Common Repository

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:41
33Computer file formats / Clinical data management / Clinical research / Electronic common technical document / Pharmaceutical industry / Marketing authorization / ACE / Doc / Specification / Zip

EU Module 1 Specification VersionRelease Notes November 2011

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:45
34Clinical research / Clinical data management / Electronic common technical document / Standards organizations

Annex 1 on Stream I: Implementation of eCTD version 4.0 (Status: Draft for eSub CMB final, datedScope This annex will provide the following details:

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:06
35Pharmaceutical industry / Clinical data management / Health informatics / Agencies of the European Union / Clinical research / Electronic common technical document / European Medicines Agency / Marketing authorization / ASMF / EMA

Annex1 - A guide to the filenaming convention for eSubmission

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:00
36Clinical data management / Clinical research / Electronic common technical document / Checksum / MD5 / HTML element

20 MarchRelease Notes for the EU eCTD Validation Criteria version 5.0 Comparison of the new major versionwith the current versionCriterion

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:08
37Digital media / Research / Clinical data management / Clinical research / Electronic common technical document / Form / Electronic submission / Email / Gateway / European Medicines Agency

Q & A for Veterinary submissions via the EMA eSubmission Gateway and Web Client

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:11
38Folder / Electronic common technical document / Directory structure / Nullsoft Scriptable Install System / Stationery

20 MarchRelease Notes for the EU NeeS Validation Criteria version 4.0 Comparison of the new major versionwith the current versionCriterion Criterion

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:08
39ISO standards / Computer file formats / Directory structure / Computer file / PDF/A / File format / Directory / System suitcase / Portable Document Format / Folder / File system / Electronic common technical document

Validation checklist-Ver 2.4 December 15

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:08
40Clinical data management / Clinical research / Electronic common technical document / Digital media / Research / Form / Email / Web page / Electronic submission / Drug Master File

Q&A for EMA Gateway Web Client

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:47
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