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Common Technical Document
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#	Item
571	[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
572	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
573	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
574	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
575	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
576	„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
577	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
578	FDA Data Exchange Standards Initiatives Regulated Product Add to Reading List Source URL: www.fda.gov Language: English Drug safety Clinical research Clinical Data Management Regulated Product Submissions Food and Drug Administration Electronic Common Technical Document Health Level 7 Submission management Prescription Drug User Fee Act Medicine Health Medical informatics
579	Microsoft Word - Non-eCTD Electronic Submission Guidance Final Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2013-07-21 04:57:54 Computing Electronic documents Medical informatics Electronic Common Technical Document Pharmaceutical industry Common Technical Document Portable Document Format Electronic signature Electronic submission Clinical research Clinical Data Management Research
580	Guidance for Industry E3 Structure and Content of Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Drug safety Clinical Data Management Electronic Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Common Technical Document Good Clinical Practice Clinical research Research Pharmaceutical sciences

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