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Common Technical Document
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81	Microsoft Word - Basic Policy on e-studysubmit for NDA.docx Add to Reading List Source URL: www.pmda.go.jp Language: English - Date: 2015-05-12 07:05:08 Food and Drug Administration Science Medical informatics Medical statistics Clinical Data Interchange Standards Consortium SDTM Clinical data acquisition Electronic Common Technical Document Clinical trial Research Clinical research Clinical Data Management
82	Consultative document in order to develop The Partnership Agreement for RomaniaMayThis document is based on technical development up to 31 May 2013 and has taken into account the version 3 of the dra Add to Reading List Source URL: www.pndr.ro Language: English - Date: 2013-06-19 04:42:49 Economy of Romania Structural Funds and Cohesion Fund Common Agricultural Policy Romania Gross domestic product Innovation EEA and Norway Grants Economy of the European Union European Union Europe
83	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Clinical research Clinical Data Management Drug safety Medical informatics Electronic Common Technical Document Investigational New Drug Common Technical Document New Drug Application Office of Regulatory Affairs Medicine Research Food and Drug Administration
84	The R4i Common Source Database (CSDB) Server enables organizations to create, manage and publish business critical content in electronic and hard copy formats. Originally designed for the defense and aerospace sectors, t Add to Reading List Source URL: www.absolutedata.com Language: English - Date: 2013-07-10 01:01:01 ISO standards Computer file formats Open formats S1000D IETM Standard Generalized Markup Language XML Portable Document Format Microsoft Excel Computing Markup languages Technical communication
85	Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Procedures, MRP and DCP (NAPs) Doc. Ref.: CMDh, Rev.1 September Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-03-10 10:40:36 Clinical Data Management Clinical research Electronic Common Technical Document
86	Training: eCTDmanager Refresher Training – One Day Duration Two days (ca. 09:00-17:00h) Agenda Timetable Add to Reading List Source URL: www.extedo.com Language: English - Date: 2012-10-31 04:50:41 Electronic Common Technical Document International Space Station CoFFEE Spaceflight Clinical Data Management Clinical research
87	TIGes/eSub CMB European Medicines Regulatory Network Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2015-05-13 07:07:09 Pharmaceutical sciences Pharmaceutical industry Clinical Data Management Medical informatics Drug safety Electronic Common Technical Document Validation Electronic submission Pharmacovigilance Clinical research Research Technology
88	Training: EURS Standard – One Day Duration One day (ca. 09:00-17:00h) Agenda Timetable Add to Reading List Source URL: www.extedo.com Language: English - Date: 2012-10-31 04:50:17 Electronic Common Technical Document Medical informatics Clinical Data Management Clinical research
89	Legacy data conversion We are embedded in CDISC colors and we intend to spread it to the World! Proprietary Information of aCROnordic Health Claim Services ApS Add to Reading List Source URL: acronordic.azurewebsites.net Language: English - Date: 2015-05-04 03:44:16 Medical informatics Statistics Food and Drug Administration Standards organizations Clinical Data Interchange Standards Consortium SDTM Electronic Common Technical Document SAS Institute SAS Clinical research Clinical Data Management Research
90	Training: eCTDmanager Standard – Two Days Duration Two days (ca. 09:00-17:00h) Agenda day 1 Timetable Add to Reading List Source URL: www.extedo.com Language: English - Date: 2012-10-31 04:50:16 Electronic Common Technical Document CoFFEE Learning Clinical Data Management Clinical research Medical informatics

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