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Clinical Data
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#	Item
241	PSUR Repository – MAH Training on new functionality Webinar training on new functionality provided in releasePresented by Kristiina Puusaari on 25 July 2016 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:01 Clinical data management Clinical research Electronic common technical document
242	Copernicus Land Monitoring Services – Validation of the Imperviousness HRL Summary of preliminary results 1. Context This summary report covers the validation of the High Resolution layer (HRL) on Imperviousness (IMD) Add to Reading List Source URL: land.copernicus.eu Language: English - Date: 2015-12-18 04:54:11 Clinical data management Clinical research Pharmaceutical industry Quality Validation Validity
243	Mandatory eCTD for Human centralised procedure ASMF submissions - Statement of Intent Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:57 Clinical research Clinical data management Electronic common technical document Digital media Research Common Technical Document
244	Microsoft PowerPoint - LPV_EGU15.pptx Add to Reading List Source URL: presentations.copernicus.org Language: English - Date: 2015-05-07 06:42:18 Clinical data management Clinical research Pharmaceutical industry Quality Validation Validity Strub
245	CMDh QUESTIONS & ANSWERS GENERIC APPLICATIONS Doc. Ref.: CMDh, Rev.1 AprilSUBMISSION OF A DESCRIPTION OF PHARMACOVIGILANCE SYSTEM AND EU RISK Add to Reading List Source URL: www.hma.eu Language: English - Date: 2016-05-16 05:10:10 Pharmaceuticals policy Pharmaceutical industry Clinical research Drug safety Healthcare quality Bioequivalence Summary of Product Characteristics Marketing authorization Test data exclusivity Pharmacovigilance Supplementary protection certificate European Medicines Agency
246	Regulations for use of Clinical Research databases, data and biomaterial samples Regulations for use of Clinical Research databases, data and biomaterial samples of the DZNE By resolution of the Clinical Board of 20 July Add to Reading List Source URL: www.dzne.de Language: English - Date: 2016-06-13 10:04:50 Clinical research Pharmaceutical industry Design of experiments Human subject research Medical ethics German Center for Neurodegenerative Diseases Clinical trial Institutional review board Good clinical practice Informed consent
247	Agenda Scottish Health Informatics Programme (SHIP) International Workshop: Secure Data Linkage & Access (Scotland) Add to Reading List Source URL: www.scot-ship.ac.uk Language: English - Date: 2014-04-01 08:14:54 Clinical data management Health research Information Services Division NHS Scotland
248	 HOME STUDY The Technology Issue: New Tools to Tackle Old Problems eSource and Risk-Based Monitoring: A Favorable Union for Future Clinical Trials Add to Reading List Source URL: www.acrpnet.org Language: English - Date: 2016-05-31 12:02:24 Clinical research Clinical data management Case report form Clinical trial Electronic health record Big data Analytics
249	EU_Clinical_Trials_search Add to Reading List Source URL: www.clinicaltrialsregister.eu Language: English - Date: 2016-07-13 04:51:15 Clinical research Design of experiments Internet search engines Clinical data management EudraCT Clinical trials registry Clinical trial Web search engine Search engine technology Phases of clinical research
250	Q&A ON THE USE OF eCTD IN MRP/DCP Doc. Ref.:CMDhRev.23 JuneAprilHow to deal with National Translations of the Product Information Question 1.1 Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-07-01 10:53:25 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Digital media Electronic submission Validation

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