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A common framework for the development of spring water contamination early warning system in western Mediterranean karst areas: Spanish and French sites.
Sci Total Environ
December 2024
Department of Geology and Centre of Hydrogeology, University of Málaga (CEHIUMA), 29071 Málaga, Spain.
Karst water resources, traditionally used worldwide for drinking purposes, are highly vulnerable to contamination. Scientific-technical efforts must therefore be done to ensure sufficient water quality for human consumption. Early-Warning-Systems emerge as an effective spring scale protection strategy for real-time identification of contamination episodes at drinking water capture points.
View Article and Find Full Text PDFEU's Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results.
Ther Innov Regul Sci
September 2024
Department of Regulatory and Quality Sciences, School of Pharmacy, University of Southern California, 1540 Alcazar Street, CHP 140, Los Angeles, CA, 90089, USA.
Background: The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process.
View Article and Find Full Text PDFThe evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards.
Cytotherapy
August 2024
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Taipa, Macao SAR, China; Centre for Pharmaceutical Regulatory Sciences, University of Macau, Taipa, Macao SAR, China; Department of Public Health and Medicinal Administration, Faculty of Health Sciences, University of Macau, Taipa, Macao SAR, China. Electronic address:
Advanced therapy medicinal products (ATMPs) are rapidly evolving to offer new treatment options. The scientific, technical, and clinical complexities subject drug regulatory authorizes to regulatory challenges. To advance the regulatory capacity for ATMPs, the National Medical Products Administration in China made changes to the drug regulatory system and developed regulatory science with the goal of addressing patient needs and encouraging innovation.
View Article and Find Full Text PDFGuidance on terminology, application, and reporting of citation searching: the TARCiS statement.
BMJ
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University Medical Library, University of Basel, 4051 Basel, Switzerland
As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. This Technical Note to the applicants puts together requirements and recommendations for the quality assessment of the methodology, analysis and reporting when DNA sequencing is used for the molecular characterisation of GM plants. In particular, it applies to the use of Sanger sequencing and next-generation sequencing for the characterisation of the inserted genetic material and its flanking regions at each insertion site, the determination of the copy number of all detectable inserts and the analysis of the genetic stability of the inserts.
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