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

Electronic common technical document
Results: 446

#	Item
11	Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDhRev.3 JuneHow to deal with National Translations of the Product Information Question 1.1 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-01 10:53:15 Clinical research Clinical data management Health Electronic common technical document Research
12	EU Module 1 Specification - Annex VersionRelease Notes November 2011 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:45 Medical research Health Pharmaceutical industry Clinical data management Clinical research Electronic common technical document Pharmaceuticals policy Marketing authorization Drug Master File
13	Release Notes detailing the updates of the EU eCTD Module 1 Specification The following aspects are addressed: 1. Under the EMA policy on publication of clinical data for medicinal products for human use, on conclusion o Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:42 Clinical data management Clinical research Universal identifiers Identifiers Health Quality Evaluation Value ethics) Electronic common technical document Universally unique identifier Globally unique identifier Validation
14	CMDh IP meeting November 2015 eSubmission Karin Gröndahl Head of Registration and Information Management, MPA, Sweden Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-11-27 10:35:36 Medical research Clinical data management Clinical research Health Electronic common technical document Pharmaceutical industry Digital media Electronic submission EudraLex Validation
15	EU Module 1 eCTD Specification VersionMay 2016 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 Computing Clinical data management Health Electronic common technical document Pharmaceuticals policy Markup languages Common Technical Document Marketing authorization Pharmacovigilance Document type definition
16	22 July 2016 EMAeSubmissions Web UI Release Notes This document lists and briefly describes the new features and fixed issues included in the release of the eSubmissions web UI component. Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:49 Clinical data management Clinical research Electronic common technical document Health Medicine
17	EU Module 1 eCTD Specification Version 3.0 October 2015 Annexes Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:42 Political philosophy Clinical data management Clinical research Electronic common technical document Health International relations European Union
18	eSubmission Gateway and Web Client – interactive Questions and Answers session on the use of updated XML delivery files Q&A Webinar Presented by Kristiina Puusaari on 25 and 26 July 2016 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:49 Computing Clinical data management Clinical research Data Electronic common technical document Health Computer file formats Markup languages
19	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 Clinical data management Clinical research Electronic common technical document Health Medicine
20	Q & A for EMA eSubmission Gateway Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:47 Medical research Health Clinical data management Clinical research Electronic common technical document Pharmaceutical industry Agencies of the European Union European Medicines Agency Form Marketing authorization Email