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

Electronic common technical document
Results: 446

#	Item
61	PSUR Repository – MAH Training on new functionality Webinar training on new functionality provided in releasePresented by Kristiina Puusaari on 25 July 2016 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:01 Clinical data management Clinical research Electronic common technical document
62	Mandatory eCTD for Human centralised procedure ASMF submissions - Statement of Intent Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:57 Clinical research Clinical data management Electronic common technical document Digital media Research Common Technical Document
63	Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDhRev.23 JuneAprilHow 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 10:53:25 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Digital media Electronic submission Validation
64	Change of future MAH Interested Parties meeting - November 2015 Problem statement • Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-11-27 10:53:15 Clinical research Clinical data management Electronic common technical document Documentation
65	London, January, 2010 EMA Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-18 07:12:04 Clinical research Clinical data management Electronic common technical document Pharmaceutical industry Common Technical Document Pharmaceuticals policy Marketing authorization ASMF Portable Document Format
66	Next Generation of Regulatory Information Management New! Add to Reading List Source URL: www.eracon.org Language: English - Date: 2015-06-15 03:34:26 Pharmacology Clinical Data Management Drug safety Medical informatics Electronic Common Technical Document Submission management Regulatory affairs Food and Drug Administration Pharmacovigilance Medicine Pharmaceutical sciences Clinical research
67	ICH eCTD Specification V 3.0 OctoberCONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2015-05-26 23:02:44 Computer file formats Medical informatics Electronic Common Technical Document Markup languages Computing Clinical Data Management Clinical research
68	M8 Electronic Common Technical Document (eCTD) v4.0 Draft Implementation Guide v2.0 Add to Reading List Source URL: www.fda.gov Language: English
69	Get ready for the new ERA of Regulatory Information Management! Add to Reading List Source URL: www.eracon.org Language: English - Date: 2013-03-28 10:30:45 Health Pharmaceutical industry Pharmaceuticals policy Clinical Data Management Medical informatics Electronic Common Technical Document Pharmacovigilance Validation Submission management Medicine Technology Clinical research
70	Benefits Fast access of submissions Manages the entire life cycle of a drug product Support of parallel work Advanced features for validation, import, display, search and Add to Reading List Source URL: preludemnc.com Language: English - Date: 2014-07-13 14:37:28 Pharmaceutical industry Research Clinical Data Management Validity Quality Electronic Common Technical Document Submission management Validation Pharmacovigilance Clinical research Technology Medicine

UPDATE