Electronic common technical document

Results: 446



#Item
51Clinical data management / Clinical research / Electronic common technical document / Digital media / Research / Electronic submission / Form / Publishing / Drug Master File

XML delivery file for all submissions via Gateway and Web Client - Statement of Intent

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:48
52Clinical data management / Clinical research / Electronic common technical document / Pharmaceuticals policy / Agencies of the European Union / European Medicines Agency / EUDRANET / Common Technical Document / Application programming interface / Repository

CR Acceptable Usage Policy

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:46
53Clinical data management / Clinical research / Electronic common technical document / European Union

EU Module 1 Specification - Annex VersionNovember 2011 Document Control

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:45
54Clinical research / Pharmaceuticals policy / Drug safety / Healthcare quality / Clinical data management / Electronic common technical document / Pharmacovigilance

CMD(h) meeting with interested parties

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Source URL: www.hma.eu

Language: English - Date: 2015-05-29 10:17:02
55Clinical research / Clinical data management / Electronic common technical document / Pharmaceutical industry / Pharmaceuticals policy / Common Technical Document / Marketing authorization / Electronic submission / Drug Master File

Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission. v2.0

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:51
56Clinical research / Clinical data management / Pharmaceutical industry / Electronic common technical document / Pharmaceuticals policy / Marketing authorization / Probability distribution / Validation

European Medicines Agency  Evaluation of Medicines for Human Use  London, August 2009  EMEA  V1.0 

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:14:52
57Clinical research / Pharmaceutical industry / Clinical data management / Drug safety / Electronic common technical document / Supplementary protection certificate / European Medicines Agency / Summary of Product Characteristics / Pharmacovigilance / Validation / Drug Master File

DOC Document

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Source URL: www.ema.europa.eu

Language: English - Date: 2016-07-20 07:22:57
58Clinical data management / Clinical research / Electronic common technical document / Digital media / Research / Electronic submission / Form / European Medicines Agency

18 March 2015 EMAProcedure Management and Business Support Division Use of XML delivery file for submissions via eSubmission Gateway / Web Client – phased implementation for all

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:16:00
59Clinical research / Clinical data management / Pharmaceutical industry / Pharmaceuticals policy / Electronic common technical document / Common Technical Document / Marketing authorization / Validation / Pharmacovigilance / HTML element / Summary of Product Characteristics / European Medicines Agency

RTF Document

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Source URL: esubmission.ema.europa.eu

Language: English - Date: 2016-08-19 03:15:41
60Computer errors / Digital media / Research / Clinical data management / Electronic common technical document / Form / Electronic submission / Email / HTTP 404 / Error message

How to send submissions via the Web Client - User Guidance

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Source URL: esubmission.ema.europa.eu

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