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Electronic common technical document
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231	Guidance Document - Creation of the Canadian Module 1 Backbone Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:53:04 Medical informatics Research Medicine Electronic Common Technical Document Drug safety Markup languages Common Technical Document Regulated Product Submissions XML Computing Clinical Data Management Clinical research
232	Notice - Canadian Module 1 Schema Version 2.2 Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:53:04 Clinical research Medical informatics Electronic Common Technical Document Common Technical Document Open formats Health Canada XML Health Products and Food Branch Computing Clinical Data Management Research
233	[removed]Federal Register / Vol. 78, No[removed]Tuesday, April 16, [removed]Notices improve global supply chain transparency by requiring owners of Add to Reading List Source URL: www.rita.dot.gov Language: English - Date: 2013-04-17 15:04:26 GPS Clinical Data Management Radio navigation Clinical research Electronic Common Technical Document Global Positioning System Endangered Species Act Federal Register Differential GPS Technology United States administrative law Navigation
234	ICH M2 EWG Work Plan 18 June 2014 Topic Adopted: 1994 Last Face-to-Face Meeting: Minneapolis, June 2014 The following roles and responsibilities of M2 were approved by the SC: 1) Provide overview of ICH and SDO technical Add to Reading List Source URL: www.ich.org Language: English Environmental Working Group Health Clinical research Clinical Data Management Electronic Common Technical Document
235	INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Final Concept Paper Addressing CTD-Q-Related Questions/Change Requests Raised by eCTD Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:07:56 Medical informatics Drug safety Electronic Common Technical Document Medicine Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Health Clinical research Research Clinical Data Management
236	Microsoft Word - Basic Policy on e-studysubmit for NDA.docx Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2014-07-10 01:52:50 Food and Drug Administration Science Medical informatics Medical statistics Clinical Data Interchange Standards Consortium SDTM Clinical data acquisition Electronic Common Technical Document Clinical trial Research Clinical research Clinical Data Management
237	Microsoft Word - QbR Frequently Asked Questions June2007.doc Add to Reading List Source URL: www.fda.gov Language: English Research Pharmacology Quality Validity Standards Electronic Common Technical Document Generic drug Food and Drug Administration Verification and validation Pharmaceutical industry Clinical research Pharmaceutical sciences
238	Microsoft Word - notice_non_ectd_hybrid_pilot_avis-eng.doc Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:39 Medical informatics Medicine Electronic Common Technical Document Common Technical Document Pharmaceutical industry Health Canada Validation Academic publishing Clinical Data Management Clinical research Research
239	General Overview of eCTD Taku Watanabe ICH M8 EWG Rapporteur Pharmaceuticals and Medical Devices Agency ©2011 ICH Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:07:55 Drug safety Medicine Medical informatics Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Investigational New Drug New Drug Application Clinical research Clinical Data Management Research
240	Microsoft Word - validation_1.0.doc Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Clinical research Medical informatics Electronic Common Technical Document Computer file formats Markup languages Corrective and preventive action Document Type Definition XML Computing Technology OSI protocols

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