Electronic common technical document - PDFSEARCH.IO - Document Search Engine

Electronic common technical document
Results: 446

#	Item
21	EU Change Control Process for Change Requests in the Entire Area of Electronic Submissions for Human Medicinal Products Version 2.1 May 2011 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:47 Medical research Clinical data management Health Clinical research Computing Network protocols Electronic common technical document Pharmaceutical industry EudraPharm Change request Change control board RDM
22	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 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English* - Date: 2016-08-19 03:14:51 Medical research Clinical data management Clinical research Health Electronic common technical document Digital media Research Common Technical Document European Medicines Agency Electronic submission Form EMA
23	EU Module 1 eCTD Specification Version 3.0 October 2015 Document Control Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:42 Medical 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
24	EMAAnnex 3. January 2015 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:59 Computing Software Archive formats Clinical data management Clinical research Electronic common technical document Computer file formats Filename Zip Ar Naming convention Form
25	EU Module 1 Specification VersionNovember 2011 Document Control Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:45 Computing 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
26	Gateway user guide xml delivery files Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:47 Medical research Pharmaceutical industry Health Clinical data management Health informatics Clinical research Electronic common technical document Pharmaceuticals policy Marketing authorization
27	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 03:16:01 Computing Health Clinical data management Clinical research Data Electronic common technical document Markup languages Computer file formats European Medicines Agency
28	Implementation guide for EU eCTD M1 specification Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:07 Clinical data management Clinical research Universal identifiers Identifiers Quality Health Evaluation Value Electronic common technical document Universally unique identifier Validation Globally unique identifier
29	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- Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:07 Computing Clinical data management Clinical research Data Pharmaceutical industry Health Electronic common technical document Publishing Readability Validation
30	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 03:16:10 Computing Data Markup languages Computer file formats Clinical data management Clinical research Electronic common technical document