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Electronic common technical document
Results: 446

#	Item
431	Guidance for Industry Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document U.S. Department of Health and Human Services Add to Reading List Source URL: www.medauthor.com Language: English - Date: 2011-07-20 19:53:32 Food and Drug Administration Human spaceflight Manned spacecraft Electronic Common Technical Document Common Technical Document International Space Station New Drug Application Center for Biologics Evaluation and Research Spaceflight Clinical research Clinical Data Management
432	eCTD Agency expectations and impact for the industry Sibylle Teuchmann, Exalon GmbH Agenda Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:01 Digital media Research Computing Knowledge Electronic Common Technical Document Common Technical Document Submission management Electronic submission Document management system Clinical Data Management Clinical research Competitions
433	About Exalon Where to find us Working for the global Pharmaceutical Industry we submitted the first eCTD Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:19 Electronic Common Technical Document Management Outsourcing Business Economics Knowledge Clinical Data Management Clinical research Medical informatics
434	[removed]eCTD Conference Istanbul Realizing eCTD capability with external providers: Points to consider Sibylle Teuchmann Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:08 Clinical research Medical informatics Electronic Common Technical Document Outsourcing Software as a service Strategic management Business Management Computing
435	Switching from Paper/NeeS to eCTD: The importance of baseline eCTDs userBridge[removed][removed], Frankfurt Dr. Michael Braun Exalon GmbH Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:11 Research Electronic Common Technical Document Computing Baseline Medicine Clinical research Clinical Data Management Medical informatics
436	Realising eCTD Capability with External Providers Sibylle Teuchmann Exalon GmbH Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:13 Medical informatics Research Electronic Common Technical Document Software Drug Information Association Microsoft PowerPoint Strategic management Outsourcing Management Clinical research Business
437	userBridge.09 Parallel eCTD Submission to EU, US, CA Practical Experience from a Service Provider Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:00 Medical informatics Medicine Electronic Common Technical Document Food and Drug Administration Clinical Data Interchange Standards Consortium SDTM Case report form Hyperlink Clinical Data Management Research Clinical research
438	Transitioning to Electronic-Only Submissions in the MRP, DCP and National Procedures: A Case Study for a Small Company Working with a Service Organisation Sibylle Teuchmann Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:02:58 Digital media Research Knowledge Education Electronic Common Technical Document Submission management Document management system Systems engineering process Electronic submission Clinical Data Management Clinical research Competitions
439	„Vom CTD zum eCTD“ [removed][removed], Vienna Switching from Paper to eCTD: Real life examples Dr. Michael Braun Add to Reading List Source URL: www.exalon.com Language: English - Date: 2014-04-15 09:03:05 Research Electronic Common Technical Document Medicine Pharmaceuticals policy Pharmaceutical industry Marketing authorization European Union Clinical Data Management Clinical research Medical informatics
440	Microsoft Word - Pathway_Regulatory_Oct09.doc Add to Reading List Source URL: www.arcs.com.au Language: English - Date: 2012-06-07 03:19:54 Pharmacology Clinical Data Management Pharmacokinetics Electronic Common Technical Document Common Technical Document Bioequivalence Regulatory affairs Bioavailability Pharmaceutical industry Pharmaceutical sciences Clinical research Research

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