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Electronic common technical document
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1	TIGes vet Q&A-update - Sept 2013 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:08 Pharmaceuticals 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
2	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 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:41 Clinical data management Clinical research Health Electronic common technical document Evaluation Pharmaceutical industry Validation
3	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 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:10 Medical research Clinical research Health Clinical data management Computing Electronic common technical document Pharmaceutical industry Pharmaceuticals policy Marketing authorization Section Diff utility Drug Master File
4	1 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:40 Pharmaceuticals 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
5	Submissions to the PSUR Repository using EMA Gateway/Web Client Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:05 Knowledge Clinical data management Clinical research Electronic common technical document Health Research Open access Institutional repository
6	PSUR Submissions in Single Assessment via EMA Gateway Webclient An agency of the European Union Presenters of the Day, from EMA Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:50 Medical 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
7	Error! No text of specified style in document. <> "Error"eSubmission Gateway Web Client \ MERGEFORMAT eSubmission Gateway Web Client Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:59 Health 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
8	eAF Question and Answers - update-KM_CPh-KP Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:02 Medical research Health Clinical data management Clinical research Pharmaceuticals policy European Medicines Agency European Union EudraLex Electronic common technical document Validation
9	E-submission Guideline-Ver.2.0-Feb2011 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:51 Computing Data management Software ISO standards Digital media Research Clinical data management Electronic common technical document Computer file Portable Document Format Directory structure Folder
10	BAP_Appendix_v1 0_June 2013 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:06 Digital 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