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Electronic common technical document
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401	Guidance for Industry M4: Organization of the CTD U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Pharmacology Common Technical Document Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document Clinical trial Food and Drug Administration Research Clinical research Pharmaceutical sciences
402	Specification for Transmitting Electronic Submissions using eCTD Backbone Specifications Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medical informatics Electronic Common Technical Document Competitions Digital media USB flash drive Universal Serial Bus Linear Tape-Open Digital Linear Tape Computer hardware Computing Clinical Data Management
403	Microsoft Word[removed]6_MK signed_8[removed]doc Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Pharmaceutical sciences Pharmaceutical industry Clinical research Clinical Data Management Investigational New Drug Title 21 CFR Part 11 Electronic Common Technical Document Electronic signature Medicine Food and Drug Administration Health
404	Providing Submissions in Electronic Format -- Summary Level Clinical Site Data for CDER Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical industry Pharmacology Medical informatics Electronic Common Technical Document Clinical investigator New Drug Application Center for Drug Evaluation and Research Food and Drug Administration Research Clinical research
405	GUIDELINE FOR GOOD CLINICAL PRACTICE Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:07:22 Science Electronic Common Technical Document Common Technical Document Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial HTML element Documentation Clinical research Research Clinical Data Management
406	5161 Specifications 508 FINAL Version 1.4.doc Add to Reading List Source URL: www.fda.gov Language: English Medicine Medical informatics Pharmacology Computer file formats Electronic Common Technical Document MedDRA XML Structured Product Labeling HTML Computing Markup languages Technical communication
407	Microsoft Word - HMA Stakeholders Information_Nov.doc Add to Reading List Source URL: www.hma.eu Language: English - Date: 2008-11-14 08:19:51 Electronic Common Technical Document Clinical research Research Clinical Data Management
408	Section 8: IT Information Systems Introduction IT information systems play a crucial role in promoting and strengthening the protection of public health. The establishment of a pan-European information system for the pha Add to Reading List Source URL: www.hma.eu Language: English - Date: 2006-12-27 06:24:43 Pharmaceuticals policy Health Clinical Data Management Drug safety Pharmacovigilance Electronic Common Technical Document Validation EUDRANET EudraVigilance Clinical research Pharmaceutical sciences Research
409	An Extension of Your Team DEDICATION We Listen Quality Implementation Services, Inc. Add to Reading List Source URL: www.qisfdaconsultants.com Language: English - Date: 2008-12-09 05:59:24 Research Pharmaceutical sciences Science Quality Clinical Data Management Validation Verification and validation Electronic Common Technical Document Protocol Clinical research Pharmaceutical industry Validity
410	STAKEHOLDERS’ INFORMATION STRATEGIC HMA WORKSHOP ON e-READINESS AT THE EUROPEAN MEDICINES NETWORK 12 April 2010 in Sevilla, Spain A Strategic workshop on e-readiness at the European Medicines Agencies Network was organ Add to Reading List Source URL: www.hma.eu Language: English - Date: 2010-05-21 07:37:02 Clinical research Clinical Data Management Electronic Common Technical Document

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