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Electronic common technical document
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311	FDA Electronic Submissions Gateway (ESG) Add to Reading List Source URL: www.fda.gov Language: English Research Medicine Pharmaceutical sciences Electronic Common Technical Document Adverse Event Reporting System New Drug Application AS2 Electronic submission Title 21 CFR Part 11 Food and Drug Administration Clinical research Pharmaceutical industry
312	6 February[removed]MEETING REPORT ICH Steering Committee[removed]November 2013, Osaka, Japan Add to Reading List Source URL: www.ich.org Language: English - Date: 2014-05-15 08:05:11 Pharmaceutical sciences Pharmacology Clinical Data Management Medicine Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use MedDRA Electronic Common Technical Document Common Technical Document Clinical research Drug safety Research
313	E2B(R3) OID Information Paper Add to Reading List Source URL: www.fda.gov Language: English Universal identifiers Pharmaceutical industry Drug safety Pharmaceutical sciences Object identifier Medicine International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document IFPMA Identifiers Clinical research Research
314	Microsoft Word - GCG109F_Final_Report_of_GCG_Meeting_Yokohama_June_09.doc Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-21 12:44:44 Research Pharmaceutics Pharmacology Pharmaceuticals policy Drug safety International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document Good Clinical Practice Good manufacturing practice Clinical research Pharmaceutical industry Pharmaceutical sciences
315	Microsoft Word - ICH Public Meeting Agenda_FDA_PhRMA Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:03:12 Clinical Data Management Medical informatics Food and Drug Administration Pharmacology United States Public Health Service Electronic Common Technical Document Health Canada Pharmaceutical Research and Manufacturers of America Clinical research Medicine Research
316	Draft Guidance Document - Creation of the Canadian Module 1 Backbone Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-09 17:16:45 Medical informatics Research Medicine Electronic Common Technical Document Drug safety Markup languages Common Technical Document Regulated Product Submissions XML Clinical Data Management Computing Clinical research
317	Tokyo ICH Symposium: Hot Topics and influence on Asia Add to Reading List Source URL: www.ich.org Language: English - Date: 2013-09-23 04:21:43 Pharmaceutical industry Health Japan Pharmaceutical Manufacturers Association Clinical research Good manufacturing practice Nihonbashi Electronic Common Technical Document Pharmaceuticals policy Pharmaceutical sciences Pharmacology
318	14 November[removed]Public ICH Regional Meeting Public ICH Meeting 14 November 2008 Add to Reading List Source URL: www.ich.org Language: English - Date: 2012-06-22 05:03:12 Health International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document European Federation of Pharmaceutical Industries and Associations Pharmaceutical Research and Manufacturers of America Clinical trial State Food and Drug Administration MedDRA Clinical research Research Pharmaceutical sciences
319	DRUG MASTER FILES UNDER GDUFA: DMF Basics Arthur B. Shaw, Ph.D. DMF Expert FDA Add to Reading List Source URL: www.fda.gov Language: English Medicine Pharmaceutical sciences Health Clinical research Drug Master File Drug safety New Drug Application Electronic Common Technical Document Generic drug Food and Drug Administration Pharmaceutical industry Pharmaceuticals policy
320	eCTD Validation Update Jared Lantzy Electronic Submission Support Team Office of Business Informatics, CDER DIA Electronic Document Management 2011 February 16, 2011 Add to Reading List Source URL: www.fda.gov Language: English Computer file formats Open formats Clinical Data Management Medical informatics Electronic Common Technical Document XML Validation Portable Document Format Food and Drug Administration Computing Clinical research Research

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