The details were presented to delegates attending a conference organised by IIR Limited, entitled ' Collecting, Managing and Presenting ADR Information to Meet the New Requirements for ADR reporting in Europe ' [ London, UK; February 1995 ]....
If the medical device registrants is requested by a government official to submit the risk evaluation report, it should always be submitted directly to the National Center for ADR (Adverse Drug Reaction) Monitoring in China. Otherwise, if the risk evaluation work is self-initiated by the medical...
DILI is one of the most common and serious adverse drug reactions (ADR) [1,8]. When severe, it may cause acute liver failure (ALF) and even death [9]. So far there is still lack of indexes for easy, objective, and specific diagnosis, as well as specific treatments for DILI. The U...
The ICH Guideline E2C, Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs, achieved Step 4 in 1996, and was intended to harmonise the periodic reporting requirements to regulatory authorities and to provide, in a common format, the worldwide interval safety experience...
By now many readers will be aware that comprehensive guidelines for reporting clinical trials have been developed. At an editorial board meeting in February 1999, it was agreed that papers reporting randomized controlled trials submitted... Robert G. Newcombe - 《Journal of Orthodontics》 被引量: ...
General Law & RegulationDrug Administration Law (2019 No. 31)Regulatory basis for the development, manufacture, business operation, practical use, supervision, and administration of drug products.https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html(Chinese) ...
(Endoscopy/ Polyp Surveillance: Colonoscopy Interval for Patients with History of Adenomatous Polyps-Avoidance of Inappropriate Use) in Medicare's Physician Quality Reporting System [1], a ''pay-for-reporting'' program that provides incentives and payment adjustments for satisfactorily reporting quality ...
AN 545: Design Guidelines and Timing Closure Techniques for HardCopy ASICs © July 2010 AN-545-2.1 This application note covers topics from a timing closure perspective, for the successful migration to HardCopy® ASICs from Altera's FPGAs. The first section covers metastability, synchronous and...
[34,40], patients and parents rated their overall satisfaction with G-tube feeding as high, despite the issues related to pain and leakage. Those reporting severe problems experienced a substantial effect on their everyday lives. Despite this, parents unanimously acknowledged that when G-tube ...
Good Clinical Practice is a set of guidelines for biomedical studies which encompasses the design, conduct, termination, audit, analysis, reporting and documentation of the studies involving human subjects. The fundamental tenet of GCP is that in research on man, the interest of science and society...