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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
The Common Technical Document (CTD) is a set of specifications for an application dossier for the registration of medicine, designed for use across Europe, Japan, the United States, and beyond. [ 1 ] Major Synopsis
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
In the guideline document, EMA inspectors state that paper TMF documents may be stored in electronic eTMF systems, and after this process, that the paper may be destroyed. The use of eTMF systems for electronic storage is fully supported by the EMA in clinical trials as a replacement for paper.
Office Open XML (OOXML) format was introduced with Microsoft Office 2007 and became the default format of Microsoft Excel ever since. Excel-related file extensions of this format include:.xlsx – Excel workbook.xlsm – Excel macro-enabled workbook; same as xlsx but may contain macros and scripts.xltx – Excel template.xltm – Excel macro ...
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Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.