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Electronic common technical document
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141	eCTD Waivers: What they are When they are needed How to obtain Virginia Ventura Add to Reading List Source URL: www.fda.gov Language: English Electronic Common Technical Document Digital media Grants Filing Abbreviated New Drug Application Electronic submission Law Scientific method Learning Clinical Data Management Clinical research Medical informatics
142	29 January[removed]MEETING REPORT ICH Steering Committee 12 – 13 November 2014, Lisbon, Portugal Add to Reading List Source URL: www.ich.org Language: English - Date: 2015-01-29 03:32:29 Pharmaceutical sciences Pharmaceuticals policy Pharmaceutics Clinical Data Management Pharmacology International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Electronic Common Technical Document MedDRA Common Technical Document Clinical research Research Pharmaceutical industry
143	Adobe Customer Story Eisai gains approval for global pharmaceutical markets. Leading Japanese pharmaceutical company reduces costs and complies with international standards using Adobe Acrobat. Add to Reading List Source URL: wwwimages.adobe.com Language: English - Date: 2015-02-20 17:42:20 Technical communication tools ISO standards Graphics file formats Adobe Acrobat Portable Document Format Electronic Common Technical Document Adobe Systems Eisai Common Technical Document Software Computing Clinical Data Management
144	Wilma Writer, PhD 200 Brick House Lane • Philadelphia, PA[removed]5555 • [removed] SUMMARY: Enthusiastic, hard-working, flexible team player with immunology PhD, RAC certification, and experience Add to Reading List Source URL: www.vpul.upenn.edu Language: English - Date: 2012-08-15 14:31:17 Health Pharmaceutical industry Pharmacology Food and Drug Administration Design of experiments Medical writing Clinical trial Regulatory affairs Electronic Common Technical Document Research Clinical research Medicine
145	Microsoft Word - iso032000-final-5apr11.docx Add to Reading List Source URL: www.pdfa.org Language: English - Date: 2013-07-31 08:17:05 Reference Computer graphics Standards Graphics file formats ISO standards Electronic Common Technical Document Portable Document Format Document management system Document file format Computing Computer file formats Adobe Systems
146	The 5 Biggest Challenges of ADaM Add to Reading List Source URL: www.nesug.org Language: English - Date: 2010-11-07 17:42:01 Research Clinical research Clinical trials Standards organizations Medicine Clinical Data Interchange Standards Consortium SDTM Electronic Common Technical Document Geographic information system Medical informatics Clinical Data Management Statistics
147	Microsoft Word - chap1.new.doc Add to Reading List Source URL: support.sas.com Language: English - Date: 2007-10-19 18:38:03 Pharmaceutical industry Food and Drug Administration Clinical Data Management Pharmacology Clinical Data Interchange Standards Consortium Clinical trial Investigational New Drug SDTM Electronic Common Technical Document Clinical research Research Pharmaceutical sciences
148	CDISC SDTM Implementation Process Michael Todd President Add to Reading List Source URL: www.nthanalytics.com Language: English - Date: 2010-02-09 22:16:49 Medical informatics Medicine Clinical trials Food and Drug Administration Clinical Data Interchange Standards Consortium SDTM Electronic Common Technical Document Bioequivalence Standard for Exchange of Non-clinical Data Research Clinical research Clinical Data Management
149	CDER Data Standards Strategy Add to Reading List Source URL: www.fda.gov Language: English Medicine Medical informatics Clinical Data Management Clinical trials Clinical Data Interchange Standards Consortium Electronic Common Technical Document Adverse Event Reporting System SDTM Center for Biologics Evaluation and Research Research Food and Drug Administration Clinical research
150	Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human APPLICANT’S RESPONSE DOCUMENT IN MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES RECOMMENDED CTD FORMATFOR MARKETING AUTHORISATION Add to Reading List Source URL: www.hma.eu Language: English - Date: 2012-03-08 05:45:57 Electronic Common Technical Document Email Technology Computing Clinical Data Management Clinical research

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