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Electronic common technical document
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81	Next Generation of Regulatory Information Management New! Add to Reading List Source URL: www.eracon.org Language: English - Date: 2015-02-16 06:18:20 Knowledge Technology Education Electronic Common Technical Document Submission management Regulation EMC Corporation Regulatory affairs Clinical research Clinical Data Management Medical informatics
82	backbone files spec module 1 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Computer file formats Open formats Electronic Common Technical Document XML Document Type Definition HTML element Investigational New Drug Attribute Computing Markup languages Clinical Data Management
83	Future direction: CDISC - an integrated part of eCTD May 2015 aCROnordic - CDISC Legacy Data Conversion Services Add to Reading List Source URL: acronordic.azurewebsites.net Language: English - Date: 2015-05-03 09:12:37 Medical informatics Clinical Data Management Food and Drug Administration Standards organizations Clinical Data Interchange Standards Consortium Prescription Drug User Fee Act Electronic Common Technical Document Clinical trial Research Clinical research Health
84	ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH eCTD Specification Change Control V1.8 ICH e Add to Reading List Source URL: estri.org Language: English - Date: 2012-06-05 01:13:00 Drug safety Standards Medical informatics Electronic Common Technical Document Medicine Technology International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Change control Specification Clinical research Research Clinical Data Management
85	Requirements on Submissions (number and format) for New Applications within MRP, DCP and National Procedures Doc. Ref.: CMDhRev.16 AprilNew submissions should generally be submitted in eCTD format (highl Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-04-29 10:02:08 Clinical Data Management Clinical research Electronic Common Technical Document
86	Requirements on submissions (number and format) for Variations and Renewals within MRP and National Procedures Doc. Ref.: CMDhRev.14 AprilSubmissions should generally be submitted in eCTD format (highly Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-04-29 10:02:09 Electronic signage Clinical Data Management Clinical research Electronic Common Technical Document
87	Document Title: TIGes Vet Group for eSubmission In the Veterinary Sector: Terms of Reference Document Version: Document Ref.: Document Status: Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2015-05-07 06:59:53 Evaluation Medicine Standards Medical informatics Technical communication Veterinary Medicines Directorate Veterinary physician Validation Electronic Common Technical Document Clinical research Quality Research
88	eAF-Release-Notes-MAAH_1 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2015-05-07 06:59:19 Electronic Common Technical Document HTML element Portable Document Format DETAIL Computing Clinical Data Management Clinical research
89	EX_Fly-Prod_EURS_2014.indd Add to Reading List Source URL: www.extedo.com Language: English - Date: 2014-09-02 09:07:25 Pharmaceutical sciences Knowledge Clinical Data Management Validity Quality Electronic Common Technical Document Submission management Validation Pharmacovigilance Clinical research Pharmaceutical industry Research
90	Microsoft Word - CMDhRev3-Clean_2011 11.doc Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2015-05-07 06:59:30 Medical informatics Electronic Common Technical Document Technology Pharmaceutical industry Science Common Technical Document Validation Electronic submission Audio power Clinical research Clinical Data Management Research

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